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1. Effects of Single Pill Combinations Compared to Identical Multi Pill Therapy on Outcomes in Hypertension, Dyslipidemia and Secondary Cardiovascular Prevention: The START-Study

Author

Wilke T, Weisser B, Predel HG, Schmieder R, Wassmann S, Gillessen A, Blettenberg J, Maywald U, Randerath O, Mueller S, and Böhm M

Subjects
single pill, adherence, cardiovascular outcomes, mortality, prognosis, clinical practice, Internal medicine, RC31-1245
Abstract

Thomas Wilke,1 Burkhard Weisser,2 Hans-Georg Predel,3 Roland Schmieder,4 Sven Wassmann,5 Anton Gillessen,6 Jörg Blettenberg,7 Ulf Maywald,8 Olaf Randerath,9 Sabrina Mueller,10 Michael Böhm11 1Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM)/Institute for Pharmacoeconomics and Pharmaceutical Logistics, Wismar, Germany; 2Institute of Sports Science, Christian-Albrechts-University of Kiel, Kiel, Germany; 3Institute of Cardiology and Sports Medicine, German Sport University, Cologne, Germany; 4Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen Nürnberg, Erlangen, Germany; 5Faculty of Medicine, Cardiology Pasing, Munich and University of the Saarland, Homburg/Saar, Germany; 6Department of Internal Medicine, Herz-Jesu-Hospital, Münster, Germany; 7Practice Dr. J. Blettenberg, Lindlar, Germany; 8AOK PLUS – The Health Insurance for Sachsen und Thüringen; GB Medicines/Remedies, Dresden, Germany; 9Medical Department, APONTIS PHARMA GmbH & Co.KG, Monheim, Germany; 10Ingress-Health HWM GmbH, Wismar, Germany; 11Clinic for Internal Medicine III, University Clinic of Saarland, Saarland University, Homburg/Saar, GermanyCorrespondence: Thomas Wilke, Institute of Pharmacoeconomics and Medication Logistics, University of Wismar, Alter Holzhafen 19, Wismar, 23966, Germany, Tel +4938417581014, Fax +4938417581011, Email Thomas.wilke@ipam-wismar.deAim: Current guidelines for the treatment of arterial hypertension (AH) or cardiovascular (CV) prevention recommend combination drug treatments with single pill combinations (SPC) to improve adherence to treatment. We aimed to assess whether the SPC concept is clinically superior to multi pill combination (MPC) with identical drugs.Methods and Results: In an explorative study, we analyzed anonymized claims data sets of patients treated with CV drugs for hypertension and/or CV disorders who were insured by the German AOK PLUS statutory health fund covering 01/07/2012-30/06/2018. Patients at age ≥ 18 years who received either a SPC or MPC with identical drugs were followed for up to one year. A one to one propensity score matching (PSM) was applied within patient groups who started identical drug combinations, and results were reported as incidence rate ratios (IRRs) as well as hazard ratios (HRs). After PSM, data from 59,336 patients were analyzed. In 30 out of 56 IRR analyses, superiority of SPC over MPC was shown. In 5 out of 7 comparisons, the HR for the composite outcome of all-cause death and all-cause hospitalizations was in favor of the SPC regimen (SPC versus MPC): valsartan/amlodipine: HR=0.87 (95% CI: 0.84– 0.91, p ≤ 0.001); candesartan/amlodipine: 0.77 (95% CI: 0.65– 0.90, p = 0.001); valsartan/amlodipine/hydrochlorothiazide: HR=0.68 (95% CI: 0.61– 0.74, p ≤ 0.001); ramipril/amlodipine: HR=0.80 (95% CI: 0.77– 0.83, p ≤ 0.001); acetylsalicylic acid (ASA)/atorvastatin/ramipril: HR=0.64 (95% CI: 0.47– 0.88, p = 0.005).Conclusion: SPC regimens are associated with a lower incidence of CV events and lower all-cause mortality in clinical practice. SPC regimens should generally be preferred to improve patient’s prognosis.Keywords: single pill, adherence, cardiovascular outcomes, mortality, prognosis, clinical practice

Published
2022

3. Management of patients with hypertension and chronic kidney disease referred to Hypertension Excellence Centres among 27 countries. On behalf of the European Society of Hypertension Working Group on Hypertension and the Kidney

Author

Halimi, J, Sarafidis, P, Azizi, M, Bilo, G, Burkard, T, Bursztyn, M, Camafort, M, Chapman, N, Cottone, S, de Backer, T, Deinum, J, Delmotte, P, Dorobantu, M, Doumas, M, Dusing, R, Duly-Bouhanick, B, Fauvel, J, Fesler, P, Gaciong, Z, Gkaliagkousi, E, Gordin, D, Grassi, G, Grassos, C, Guerrot, D, Huart, J, Izzo, R, Jaén Águila, F, Járai, Z, Kahan, T, Kantola, I, Kociánová, E, Limbourg, F, Lopez-Sublet, M, Mallamaci, F, Manolis, A, Marketou, M, Mayer, G, Mazza, A, Macintyre, I, Mourad, J, Muiesan, M, Nasr, E, Nilsson, P, Oliveras, A, Ormezzano, O, Paixão-Dias, V, Papadakis, I, Papadopoulos, D, Perl, S, Polónia, J, Pontremoli, R, Pucci, G, Robles, N, Rubin, S, Ruilope, L, Rump, L, Saeed, S, Sanidas, E, Sarzani, R, Schmieder, R, Silhol, F, Sokolovic, S, Solbu, M, Soucek, M, Stergiou, G, Sudano, I, Tabbalat, R, Tengiz, I, Triantafyllidi, H, Tsioufis, K, Václavík, J, van der Giet, M, der Niepen, P, Veglio, F, Venzin, R, Viigimaa, M, Weber, T, Widimsky, J, Wuerzner, G, Zelveian, P, Zebekakis, P, Lueders, S, Persu, A, Kreutz, R, Vogt, L, Halimi JM, Sarafidis P, Azizi M, Bilo G, Burkard T, Bursztyn M, Camafort M, Chapman N, Cottone S, de Backer T, Deinum J, Delmotte P, Dorobantu M, Doumas M, Dusing R, Duly-Bouhanick B, Fauvel JP, Fesler P, Gaciong Z, Gkaliagkousi E, Gordin D, Grassi G, Grassos C, Guerrot D, Huart J, Izzo R, Jaén Águila F, Járai Z, Kahan T, Kantola I, Kociánová E, Limbourg F, Lopez-Sublet M, Mallamaci F, Manolis A, Marketou M, Mayer G, Mazza A, MacIntyre I, Mourad JJ, Muiesan ML, Nasr E, Nilsson P, Oliveras A, Ormezzano O, Paixão-Dias V, Papadakis I, Papadopoulos D, Perl S, Polónia J, Pontremoli R, Pucci G, Robles NR, Rubin S, Ruilope LM, Rump LC, Saeed S, Sanidas E, Sarzani R, Schmieder R, Silhol F, Sokolovic S, Solbu M, Soucek M, Stergiou G, Sudano I, Tabbalat R, Tengiz I, Triantafyllidi H, Tsioufis K, Václavík J, van der Giet M, der Niepen PV, Veglio F, Venzin R, Viigimaa M, Weber T, Widimsky J, Wuerzner G, Zelveian P, Zebekakis P, Lueders S, Persu A, Kreutz R, Vogt L., Halimi, J, Sarafidis, P, Azizi, M, Bilo, G, Burkard, T, Bursztyn, M, Camafort, M, Chapman, N, Cottone, S, de Backer, T, Deinum, J, Delmotte, P, Dorobantu, M, Doumas, M, Dusing, R, Duly-Bouhanick, B, Fauvel, J, Fesler, P, Gaciong, Z, Gkaliagkousi, E, Gordin, D, Grassi, G, Grassos, C, Guerrot, D, Huart, J, Izzo, R, Jaén Águila, F, Járai, Z, Kahan, T, Kantola, I, Kociánová, E, Limbourg, F, Lopez-Sublet, M, Mallamaci, F, Manolis, A, Marketou, M, Mayer, G, Mazza, A, Macintyre, I, Mourad, J, Muiesan, M, Nasr, E, Nilsson, P, Oliveras, A, Ormezzano, O, Paixão-Dias, V, Papadakis, I, Papadopoulos, D, Perl, S, Polónia, J, Pontremoli, R, Pucci, G, Robles, N, Rubin, S, Ruilope, L, Rump, L, Saeed, S, Sanidas, E, Sarzani, R, Schmieder, R, Silhol, F, Sokolovic, S, Solbu, M, Soucek, M, Stergiou, G, Sudano, I, Tabbalat, R, Tengiz, I, Triantafyllidi, H, Tsioufis, K, Václavík, J, van der Giet, M, der Niepen, P, Veglio, F, Venzin, R, Viigimaa, M, Weber, T, Widimsky, J, Wuerzner, G, Zelveian, P, Zebekakis, P, Lueders, S, Persu, A, Kreutz, R, Vogt, L, Halimi JM, Sarafidis P, Azizi M, Bilo G, Burkard T, Bursztyn M, Camafort M, Chapman N, Cottone S, de Backer T, Deinum J, Delmotte P, Dorobantu M, Doumas M, Dusing R, Duly-Bouhanick B, Fauvel JP, Fesler P, Gaciong Z, Gkaliagkousi E, Gordin D, Grassi G, Grassos C, Guerrot D, Huart J, Izzo R, Jaén Águila F, Járai Z, Kahan T, Kantola I, Kociánová E, Limbourg F, Lopez-Sublet M, Mallamaci F, Manolis A, Marketou M, Mayer G, Mazza A, MacIntyre I, Mourad JJ, Muiesan ML, Nasr E, Nilsson P, Oliveras A, Ormezzano O, Paixão-Dias V, Papadakis I, Papadopoulos D, Perl S, Polónia J, Pontremoli R, Pucci G, Robles NR, Rubin S, Ruilope LM, Rump LC, Saeed S, Sanidas E, Sarzani R, Schmieder R, Silhol F, Sokolovic S, Solbu M, Soucek M, Stergiou G, Sudano I, Tabbalat R, Tengiz I, Triantafyllidi H, Tsioufis K, Václavík J, van der Giet M, der Niepen PV, Veglio F, Venzin R, Viigimaa M, Weber T, Widimsky J, Wuerzner G, Zelveian P, Zebekakis P, Lueders S, Persu A, Kreutz R, and Vogt L.

Abstract

Objective Real-life management of patients with hypertension and chronic kidney disease (CKD) among European Society of Hypertension Excellence Centres (ESH-ECs) is unclear : we aimed to investigate it. Methods A survey was conducted in 2023. The questionnaire contained 64 questions asking ESH-ECs representatives to estimate how patients with CKD are managed. Results Overall, 88 ESH-ECS representatives from 27 countries participated. According to the responders, renin-angiotensin system (RAS) blockers, calcium-channel blockers and thiazides were often added when these medications were lacking in CKD patients, but physicians were more prone to initiate RAS blockers (90% [interquartile range: 70–95%]) than MRA (20% [10–30%]), SGLT2i (30% [20–50%]) or (GLP1-RA (10% [5–15%]). Despite treatment optimisation, 30% of responders indicated that hypertension remained uncontrolled (30% (15–40%) vs 18% [10%–25%]) in CKD and CKD patients, respectively). Hyperkalemia was the most frequent barrier to initiate RAS blockers, and dosage reduction was considered in 45% of responders when kalaemia was 5.5–5.9 mmol/L. Conclusions RAS blockers are initiated in most ESH-ECS in CKD patients, but MRA and SGLT2i initiations are less frequent. Hyperkalemia was the main barrier for initiation or adequate dosing of RAS blockade, and RAS blockers’ dosage reduction was the usual management.

Published
2024

4. Screening and management of hypertensive patients with chronic kidney disease referred to Hypertension Excellence Centres among 27 countries. A pilot survey based on questionnaire

Author

Halimi, J, Sarafidis, P, Azizi, M, Bilo, G, Burkard, T, Bursztyn, M, Camafort, M, Chapman, N, Cottone, S, de Backer, T, Deinum, J, Delmotte, P, Dorobantu, M, Doumas, M, Dusing, R, Duly-Bouhanick, B, Fauvel, J, Fesler, P, Gaciong, Z, Gkaliagkousi, E, Gordin, D, Grassi, G, Grassos, C, Guerrot, D, Huart, J, Izzo, R, Águila, F, Járai, Z, Kahan, T, Kantola, I, Kociánová, E, Limbourg, F, Lopez-Sublet, M, Mallamaci, F, Manolis, A, Marketou, M, Mayer, G, Mazza, A, Macintyre, I, Mourad, J, Muiesan, M, Nasr, E, Nilsson, P, Oliveras, A, Ormezzano, O, Paixão-Dias, V, Papadakis, I, Papadopoulos, D, Perl, S, Polónia, J, Pontremoli, R, Pucci, G, Robles, N, Rubin, S, Ruilope, L, Rump, L, Saeed, S, Sanidas, E, Sarzani, R, Schmieder, R, Silhol, F, Sokolovic, S, Solbu, M, Soucek, M, Stergiou, G, Sudano, I, Tabbalat, R, Tengiz, I, Triantafyllidi, H, Tsioufis, K, Václavík, J, van der Giet, M, Van der Niepen, P, Veglio, F, Venzin, R, Viigimaa, M, Weber, T, Widimsky, J, Wuerzner, G, Zelveian, P, Zebekakis, P, Lueders, S, Persu, A, Kreutz, R, Vogt, L, Halimi JM, Sarafidis P, Azizi M, Bilo G, Burkard T, Bursztyn M, Camafort M, Chapman N, Cottone S, de Backer T, Deinum J, Delmotte P, Dorobantu M, Doumas M, Dusing R, Duly-Bouhanick B, Fauvel JP, Fesler P, Gaciong Z, Gkaliagkousi E, Gordin D, Grassi G, Grassos C, Guerrot D, Huart J, Izzo R, Águila FJ, Járai Z, Kahan T, Kantola I, Kociánová E, Limbourg FP, Lopez-Sublet M, Mallamaci F, Manolis A, Marketou M, Mayer G, Mazza A, MacIntyre IM, Mourad JJ, Muiesan ML, Nasr E, Nilsson P, Oliveras A, Ormezzano O, Paixão-Dias V, Papadakis I, Papadopoulos D, Perl S, Polónia J, Pontremoli R, Pucci G, Robles NR, Rubin S, Ruilope LM, Rump LC, Saeed S, Sanidas E, Sarzani R, Schmieder R, Silhol F, Sokolovic S, Solbu M, Soucek M, Stergiou G, Sudano I, Tabbalat R, Tengiz I, Triantafyllidi H, Tsioufis K, Václavík J, van der Giet M, Van der Niepen P, Veglio F, Venzin RM, Viigimaa M, Weber T, Widimsky J, Wuerzner G, Zelveian P, Zebekakis P, Lueders S, Persu A, Kreutz R, Vogt L, Halimi, J, Sarafidis, P, Azizi, M, Bilo, G, Burkard, T, Bursztyn, M, Camafort, M, Chapman, N, Cottone, S, de Backer, T, Deinum, J, Delmotte, P, Dorobantu, M, Doumas, M, Dusing, R, Duly-Bouhanick, B, Fauvel, J, Fesler, P, Gaciong, Z, Gkaliagkousi, E, Gordin, D, Grassi, G, Grassos, C, Guerrot, D, Huart, J, Izzo, R, Águila, F, Járai, Z, Kahan, T, Kantola, I, Kociánová, E, Limbourg, F, Lopez-Sublet, M, Mallamaci, F, Manolis, A, Marketou, M, Mayer, G, Mazza, A, Macintyre, I, Mourad, J, Muiesan, M, Nasr, E, Nilsson, P, Oliveras, A, Ormezzano, O, Paixão-Dias, V, Papadakis, I, Papadopoulos, D, Perl, S, Polónia, J, Pontremoli, R, Pucci, G, Robles, N, Rubin, S, Ruilope, L, Rump, L, Saeed, S, Sanidas, E, Sarzani, R, Schmieder, R, Silhol, F, Sokolovic, S, Solbu, M, Soucek, M, Stergiou, G, Sudano, I, Tabbalat, R, Tengiz, I, Triantafyllidi, H, Tsioufis, K, Václavík, J, van der Giet, M, Van der Niepen, P, Veglio, F, Venzin, R, Viigimaa, M, Weber, T, Widimsky, J, Wuerzner, G, Zelveian, P, Zebekakis, P, Lueders, S, Persu, A, Kreutz, R, Vogt, L, Halimi JM, Sarafidis P, Azizi M, Bilo G, Burkard T, Bursztyn M, Camafort M, Chapman N, Cottone S, de Backer T, Deinum J, Delmotte P, Dorobantu M, Doumas M, Dusing R, Duly-Bouhanick B, Fauvel JP, Fesler P, Gaciong Z, Gkaliagkousi E, Gordin D, Grassi G, Grassos C, Guerrot D, Huart J, Izzo R, Águila FJ, Járai Z, Kahan T, Kantola I, Kociánová E, Limbourg FP, Lopez-Sublet M, Mallamaci F, Manolis A, Marketou M, Mayer G, Mazza A, MacIntyre IM, Mourad JJ, Muiesan ML, Nasr E, Nilsson P, Oliveras A, Ormezzano O, Paixão-Dias V, Papadakis I, Papadopoulos D, Perl S, Polónia J, Pontremoli R, Pucci G, Robles NR, Rubin S, Ruilope LM, Rump LC, Saeed S, Sanidas E, Sarzani R, Schmieder R, Silhol F, Sokolovic S, Solbu M, Soucek M, Stergiou G, Sudano I, Tabbalat R, Tengiz I, Triantafyllidi H, Tsioufis K, Václavík J, van der Giet M, Van der Niepen P, Veglio F, Venzin RM, Viigimaa M, Weber T, Widimsky J, Wuerzner G, Zelveian P, Zebekakis P, Lueders S, Persu A, Kreutz R, and Vogt L

Abstract

Objective: Real-life management of hypertensive patients with chronic kidney disease (CKD) is unclear. Methods: A survey was conducted in 2023 by the European Society of Hypertension (ESH) to assess management of CKD patients referred to ESH-Hypertension Excellence Centres (ESH-ECs) at first referral visit. The questionnaire contained 64 questions with which ESH-ECs representatives were asked to estimate preexisting CKD management quality. Results: Overall, 88 ESH-ECs from 27 countries participated (fully completed surveys: 66/88 [75.0%]). ESH-ECs reported that 28% (median, interquartile range: 15–50%) had preexisting CKD, with 10% of them (5–30%) previously referred to a nephrologist, while 30% (15–40%) had resistant hypertension. The reported rate of previous recent (<6months) estimated glomerular filtration rate (eGFR) and urine albumin–creatinine ratio (UACR) testing were 80% (50–95%) and 30% (15–50%), respectively. The reported use of renin-angiotensin system blockers was 80% (70–90%). When a nephrologist was part of the ESH-EC teams the reported rates SGLT2 inhibitors (27.5% [20 – 40%] vs. 15% [10 – 25], P 1⁄4 0.003), GLP1-RA (10% [10 – 20%] vs. 5% [5 – 10%], P 1⁄4 0.003) and mineralocorticoid receptor antagonists (20% [10 – 30%] vs. 15% [10 – 20%], P 1⁄4 0.05) use were greater as compared to ESH-ECs without nephrologist participation. The rate of reported resistant hypertension, recent eGFR and UACR results and management of CKD patients prior to referral varied widely across countries. Conclusions: Our estimation indicates deficits regarding CKD screening, use of nephroprotective drugs and referral to nephrologists before referral to ESH-ECs but results varied widely across countries. This information can be used to build specific programs to improve care in hypertensives with CKD.

Published
2024

5. Populationsbasiertes Screening bei Kindern zur Früherkennung und Behandlung der familiären Hypercholesterinämie: Die Vroni-Studie.

Author

Leipold, G., Veronika, S., Schmieder, R., Arens, S., Kordonouri, O., and Schunkert, H.

Subjects
LDL cholesterol, DIAGNOSIS
Abstract

The article discusses the Vroni study, which focuses on screening children for familial hypercholesterolemia (FH) during routine check-ups. The study, conducted in Bavaria, Niedersachsen, and Hamburg, aims to identify FH cases early to initiate preventive measures and reduce the risk of atherosclerotic complications. Results show a significant number of children with pathogenic FH variants, with a high rate of genetic testing acceptance. The study highlights the importance of early diagnosis, regular follow-ups, and medication therapy for FH, with plans to expand the screening program nationwide in Germany. [Extracted from the article]

Published
2025
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7. Outcomes Following Radiofrequency Renal Denervation According to Antihypertensive Medications: Subgroup Analysis of the Global SYMPLICITY Registry DEFINE

Author

Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Böhm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., Böhm M., Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Böhm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., and Böhm M.

Abstract

Background: The Global SYMPLICITY Registry DEFINE (Denervation Findings in Real World) investigates radiofrequency renal denervation (RDN) in a broad range of patients with hypertension. We evaluated whether the number or type of antihypertensive medications were associated with increased long-term blood pressure (BP) reductions and cardiovascular outcomes following radiofrequency RDN. Methods: Patients underwent radiofrequency RDN and were categorized by baseline number (0-3 and ≥4) and different combinations of medication classes. BP changes were compared between groups through 36 months. Individual and composite major adverse cardiovascular events were analyzed. Results: Of 2746 evaluable patients, 18% were prescribed 0 to 3 and 82% prescribed ≥4 classes. At 36 months, office systolic BP significantly decreased (P<0.0001) by -19.0±28.3 and -16.2±28.6 mm Hg in the 0 to 3 and ≥4 class groups, respectively. Twenty-four-hour mean systolic BP significantly decreased (P<0.0001) by -10.7±19.7 and -8.9±20.5 mm Hg, respectively. BP reduction was similar between the medication subgroups. Antihypertensive medication classes decreased from 4.6±1.4 to 4.3±1.5 (P<0.0001). Most decreased (31%) or had no changes (47%) to the number of medications, while 22% increased. The number of baseline antihypertensive medication classes was inversely related to the change in prescribed classes at 36 months (P<0.001). Cardiovascular event rates were generally low. More patients in the ≥4 compared with 0 to 3 medication classes had myocardial infarction at 36 months (2.8% versus 0.3%; P=0.009). Conclusions: Radiofrequency RDN reduced BP safely through 36 months, independent of the number and type of baseline antihypertensive medication classes. More patients decreased than increased their number of medications. Radiofrequency RDN is a safe and effective adjunctive therapy regardless of antihypertensive medication regimen. Registration: URL: https://www. Clinicaltrials: gov; Uniqu

Published
2023

14. Association between exercise frequency with renal and cardiovascular outcomes in diabetic and non-diabetic individuals at high cardiovascular risk

Author

Bohm, M, Schumacher, H, Werner, C, Teo, K, Lonn, E, Mahfoud, F, Speer, T, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Marx, N, Weber, M, Laufs, U, Williams, B, Yusuf, S, Mann, J, Bohm M., Schumacher H., Werner C., Teo K. K., Lonn E. M., Mahfoud F., Speer T., Mancia G., Redon J., Schmieder R. E., Sliwa K., Marx N., Weber M. A., Laufs U., Williams B., Yusuf S., Mann J. F. E., Bohm, M, Schumacher, H, Werner, C, Teo, K, Lonn, E, Mahfoud, F, Speer, T, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Marx, N, Weber, M, Laufs, U, Williams, B, Yusuf, S, Mann, J, Bohm M., Schumacher H., Werner C., Teo K. K., Lonn E. M., Mahfoud F., Speer T., Mancia G., Redon J., Schmieder R. E., Sliwa K., Marx N., Weber M. A., Laufs U., Williams B., Yusuf S., and Mann J. F. E.

Published
2022

15. Cardiovascular Risk Reduction After Renal Denervation According to Time in Therapeutic Systolic Blood Pressure Range

Author

Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Kao, H, Rodriguez-Leor, O, Noory, E, Ong, T, Unterseeh, T, de Araujo Goncalves, P, Zirlik, A, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Kao H. -L., Rodriguez-Leor O., Noory E., Ong T. K., Unterseeh T., de Araujo Goncalves P., Zirlik A., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., Bohm M., Mahfoud, F, Mancia, G, Schmieder, R, Ruilope, L, Narkiewicz, K, Schlaich, M, Williams, B, Ribichini, F, Weil, J, Kao, H, Rodriguez-Leor, O, Noory, E, Ong, T, Unterseeh, T, de Araujo Goncalves, P, Zirlik, A, Almerri, K, Sharif, F, Lauder, L, Wanten, M, Fahy, M, Bohm, M, Mahfoud F., Mancia G., Schmieder R. E., Ruilope L., Narkiewicz K., Schlaich M., Williams B., Ribichini F., Weil J., Kao H. -L., Rodriguez-Leor O., Noory E., Ong T. K., Unterseeh T., de Araujo Goncalves P., Zirlik A., Almerri K., Sharif F., Lauder L., Wanten M., Fahy M., and Bohm M.

Abstract

Background: Renal denervation (RDN) has been shown to lower blood pressure (BP), but its effects on cardiovascular events have only been preliminarily evaluated. Time in therapeutic range (TTR) of BP is associated with cardiovascular events. Objectives: This study sought to assess the impact of catheter-based RDN on TTR and its association with cardiovascular outcomes in the GSR (Global SYMPLICITY Registry). Methods: Patients with uncontrolled hypertension were enrolled and treated with radiofrequency RDN. Office and ambulatory systolic blood pressure (OSBP and ASBP) were measured at 3, 6, 12, 24, and 36 months postprocedure and used to derive TTR. TTR through 6 months was assessed as a predictor of cardiovascular events from 6 to 36 months using a Cox proportional hazard regression model. Results: As of March 1, 2022, 3,077 patients were enrolled: 42.2% were female; mean age was 60.5 ± 12.2 years; baseline OSBP was 165.6 ± 24.8 mm Hg; and baseline ASBP was 154.3 ± 18.7 mm Hg. Patients were prescribed 4.9 ± 1.7 antihypertensive medications at baseline and 4.8 ± 1.9 at 36 months. At 36 months, mean changes were −16.7 ± 28.4 and −9.0 ± 20.2 mm Hg for OSBP and ASBP, respectively. TTR through 6 months was 30.6%. A 10% increase in TTR after RDN through 6 months was associated with significant risk reductions from 6 to 36 months of 15% for major adverse cardiovascular events (P < 0.001), 11% cardiovascular death (P = 0.010), 15% myocardial infarction (P = 0.023), and 23% stroke (P < 0.001). Conclusions: There were sustained BP reductions and higher TTR through 36 months after RDN. A 10% increase in TTR through 6 months was associated with significant risk reductions in major cardiovascular events from 6 to 36 months. (Global SYMPLICITY Registry [GSR] DEFINE; NCT01534299)

Published
2022

16. Renal denervation in patients with versus without chronic kidney disease: Results from the Global SYMPLICITY Registry with follow-up data of 3 years

Author

Ott, C, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Fahy, M, Schlaich, M, Bohm, M, Schmieder, R, Ott C., Mahfoud F., Mancia G., Narkiewicz K., Ruilope L. M., Fahy M., Schlaich M. P., Bohm M., Schmieder R. E., Ott, C, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Fahy, M, Schlaich, M, Bohm, M, Schmieder, R, Ott C., Mahfoud F., Mancia G., Narkiewicz K., Ruilope L. M., Fahy M., Schlaich M. P., Bohm M., and Schmieder R. E.

Abstract

Background: Activity of the sympathetic nervous system is increased in patients with hypertension and chronic kidney disease (CKD). Here we compare short-and long-term blood pressure (BP)-lowering effects of renal denervation (RDN) between hypertensive patients with or without CKD in the Global SYMPLICITY Registry. Methods: Office and 24-h ambulatory BP (ABP) were assessed at prespecified time points after RDN. The presence of CKD was defined according to the estimated glomerular filtration rate (eGFR) and enrolled patients were stratified based on the presence (n = 475, eGFR <60 mL/min/1.73 m2) or absence (n = 1505, eGFR ≥60mL/min/1.73 m2) of CKD. Results: Patients with CKD were older (P < 0.001) and were prescribed more antihypertensive medications (P < 0.001). eGFR decline per year was not significantly different between groups after the first year. Office and 24-h ABP were significantly reduced from baseline at all time points after RDN in both groups (all P < 0.001). After adjusting for baseline data, patients without CKD had a greater reduction in office systolic BP (-17.3 ± 28.3 versus-11.7 ± 29.9 mmHg; P = 0.009) but not diastolic BP at 36 months compared with those with CKD. Similar BP and eGFR results were found when the analysis was limited to patients with both baseline and 36-month BP data available. There was no difference in the safety profile of the RDN procedure between groups. Conclusions: After adjusting for baseline data, 24-h systolic and diastolic ABP reduction were similar in patients with and without CKD after RDN, whereas office systolic but not diastolic BP was reduced less in patients with CKD. We conclude that RDN is an effective antihypertensive treatment option in CKD patients.

Published
2022

18. Renal Denervation: A Practical Guide for Health Professionals Managing Hypertension

Author

Schmieder, R. Burnier, M. East, C. Tsioufis, K. Delaney, S. and Schmieder, R. Burnier, M. East, C. Tsioufis, K. Delaney, S.

Abstract

Growing evidence demonstrates the suitability of renal denervation in a broad population of patients; however, questions remain over its suitability and practical implementation. Given the rapidity of emerging data, this has been a challenging field for potential adopters to navigate. The purpose of this article is twofold: to provide navigation through emerging clinical data and evolving guidance; and to provide physicians with practical, evidence-based advice for identifying eligible patients and providing appropriate management in the pre- and postintervention settings. Although many of these recommendations are based on existing published guidance documents, we reflect equally on our own experiences of using this technology. © 2023 Radcliffe Group Ltd. All rights reserved.

Published
2023

19. Clinical event reductions in high-risk patients after renal denervation projected from the global SYMPLICITY registry

Author

Schmieder, R, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Hutton, D, Cao, K, Hettrick, D, Fahy, M, Schlaich, M, Böhm, M, Pietzsch, J, Schmieder, RE, Hettrick, DA, Schlaich, MP, Pietzsch, JB, Schmieder, R, Mahfoud, F, Mancia, G, Narkiewicz, K, Ruilope, L, Hutton, D, Cao, K, Hettrick, D, Fahy, M, Schlaich, M, Böhm, M, Pietzsch, J, Schmieder, RE, Hettrick, DA, Schlaich, MP, and Pietzsch, JB

Abstract

Aims: Renal denervation has been shown to lower blood pressure in sham-controlled trials and represents a device-based treatment option for hypertension. We sought to project clinical event reductions after radiofrequency renal denervation using a novel modelling approach. Methods and results: The Global SYMPLICITY Registry is a global, prospective all-comer registry to evaluate safety and efficacy after renal denervation. For this analysis, change in office systolic blood pressure from baseline was calculated from reported follow-up in the Global SYMPLICITY Registry. Relative risks for death and other cardiovascular events as well as numbers needed to treat for event avoidance were obtained for the respective blood pressure reductions based on previously reported meta-regression analyses for the full cohort and high-risk subgroups including type 2 diabetes, chronic kidney disease, resistant hypertension, and high basal cardiovascular risk. Average baseline office systolic blood pressure and reduction estimates for the full cohort (N = 2651) were 166±25 and -14.8 ± 0.4 mmHg, respectively. Mean reductions in blood pressure ranged from -11.0 - 21.8 mmHg for the studied high-risk subgroups. Projected relative risks ranged from 0.57 for stroke in the resistant hypertension cohort to 0.92 for death in the diabetes cohort. Significant absolute reductions in major adverse cardiovascular events over 3 years compared with the projected control (8.6 ± 0.7% observed vs. 11.7 ± 0.9% for projected control; P < 0.01) were primarily due to reduced stroke incidence. The robustness of findings was confirmed in sensitivity and scenario analyses. Conclusion: Model-based projections suggest radiofrequency renal denervation for patients with uncontrolled hypertension adds considerable clinical benefit across a spectrum of different cohort characteristics.

Published
2023

20. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA)

Author

Mancia, G, Kreutz, R, Brunström, M, Burnier, M, Grassi, G, Januszewicz, A, Muiesan, M, Tsioufis, K, Agabiti-Rosei, E, Algharably, E, Azizi, M, Benetos, A, Borghi, C, Hitij, J, Cifkova, R, Coca, A, Cornelissen, V, Cruickshank, J, Cunha, P, Danser, A, Pinho, R, Delles, C, Dominiczak, A, Dorobantu, M, Doumas, M, Fernández-Alfonso, M, Halimi, J, Járai, Z, Jelaković, B, Jordan, J, Kuznetsova, T, Laurent, S, Lovic, D, Lurbe, E, Mahfoud, F, Manolis, A, Miglinas, M, Narkiewicz, K, Niiranen, T, Palatini, P, Parati, G, Pathak, A, Persu, A, Polonia, J, Redon, J, Sarafidis, P, Schmieder, R, Spronck, B, Stabouli, S, Stergiou, G, Taddei, S, Thomopoulos, C, Tomaszewski, M, Van de Borne, P, Wanner, C, Weber, T, Williams, B, Zhang, Z, Kjeldsen, S, Mancia, Giuseppe, Kreutz, Reinhold, Brunström, Mattias, Burnier, Michel, Grassi, Guido, Januszewicz, Andrzej, Muiesan, Maria Lorenza, Tsioufis, Konstantinos, Agabiti-Rosei, Enrico, Algharably, Engi Abd Elhady, Azizi, Michel, Benetos, Athanase, Borghi, Claudio, Hitij, Jana Brguljan, Cifkova, Renata, Coca, Antonio, Cornelissen, Veronique, Cruickshank, J Kennedy, Cunha, Pedro G, Danser, A H Jan, Pinho, Rosa Maria de, Delles, Christian, Dominiczak, Anna F, Dorobantu, Maria, Doumas, Michalis, Fernández-Alfonso, María S, Halimi, Jean-Michel, Járai, Zoltán, Jelaković, Bojan, Jordan, Jens, Kuznetsova, Tatiana, Laurent, Stephane, Lovic, Dragan, Lurbe, Empar, Mahfoud, Felix, Manolis, Athanasios, Miglinas, Marius, Narkiewicz, Krzystof, Niiranen, Teemu, Palatini, Paolo, Parati, Gianfranco, Pathak, Atul, Persu, Alexandre, Polonia, Jorge, Redon, Josep, Sarafidis, Pantelis, Schmieder, Roland, Spronck, Bart, Stabouli, Stella, Stergiou, George, Taddei, Stefano, Thomopoulos, Costas, Tomaszewski, Maciej, Van de Borne, Philippe, Wanner, Christoph, Weber, Thomas, Williams, Bryan, Zhang, Zhen-Yu, Kjeldsen, Sverre E, Mancia, G, Kreutz, R, Brunström, M, Burnier, M, Grassi, G, Januszewicz, A, Muiesan, M, Tsioufis, K, Agabiti-Rosei, E, Algharably, E, Azizi, M, Benetos, A, Borghi, C, Hitij, J, Cifkova, R, Coca, A, Cornelissen, V, Cruickshank, J, Cunha, P, Danser, A, Pinho, R, Delles, C, Dominiczak, A, Dorobantu, M, Doumas, M, Fernández-Alfonso, M, Halimi, J, Járai, Z, Jelaković, B, Jordan, J, Kuznetsova, T, Laurent, S, Lovic, D, Lurbe, E, Mahfoud, F, Manolis, A, Miglinas, M, Narkiewicz, K, Niiranen, T, Palatini, P, Parati, G, Pathak, A, Persu, A, Polonia, J, Redon, J, Sarafidis, P, Schmieder, R, Spronck, B, Stabouli, S, Stergiou, G, Taddei, S, Thomopoulos, C, Tomaszewski, M, Van de Borne, P, Wanner, C, Weber, T, Williams, B, Zhang, Z, Kjeldsen, S, Mancia, Giuseppe, Kreutz, Reinhold, Brunström, Mattias, Burnier, Michel, Grassi, Guido, Januszewicz, Andrzej, Muiesan, Maria Lorenza, Tsioufis, Konstantinos, Agabiti-Rosei, Enrico, Algharably, Engi Abd Elhady, Azizi, Michel, Benetos, Athanase, Borghi, Claudio, Hitij, Jana Brguljan, Cifkova, Renata, Coca, Antonio, Cornelissen, Veronique, Cruickshank, J Kennedy, Cunha, Pedro G, Danser, A H Jan, Pinho, Rosa Maria de, Delles, Christian, Dominiczak, Anna F, Dorobantu, Maria, Doumas, Michalis, Fernández-Alfonso, María S, Halimi, Jean-Michel, Járai, Zoltán, Jelaković, Bojan, Jordan, Jens, Kuznetsova, Tatiana, Laurent, Stephane, Lovic, Dragan, Lurbe, Empar, Mahfoud, Felix, Manolis, Athanasios, Miglinas, Marius, Narkiewicz, Krzystof, Niiranen, Teemu, Palatini, Paolo, Parati, Gianfranco, Pathak, Atul, Persu, Alexandre, Polonia, Jorge, Redon, Josep, Sarafidis, Pantelis, Schmieder, Roland, Spronck, Bart, Stabouli, Stella, Stergiou, George, Taddei, Stefano, Thomopoulos, Costas, Tomaszewski, Maciej, Van de Borne, Philippe, Wanner, Christoph, Weber, Thomas, Williams, Bryan, Zhang, Zhen-Yu, and Kjeldsen, Sverre E

Abstract

Luis Alcocer (Mexico), Christina Antza (Greece), Mustafa Arici (Turkey), Eduardo Barbosa (Brazil), Adel Berbari (Lebanon), Luís Bronze (Portugal), John Chalmers (Australia), Tine De Backer (Belgium), Alejandro de la Sierra (Spain), Kyriakos Dimitriadis (Greece), Dorota Drozdz (Poland), Béatrice Duly-Bouhanick (France), Brent M. Egan (USA), Serap Erdine (Turkey), Claudio Ferri (Italy), Slavomira Filipova (Slovak Republic), Anthony Heagerty (UK), Michael Hecht Olsen (Denmark), Dagmara Hering (Poland), Sang Hyun Ihm (South Korea), Uday Jadhav (India), Manolis Kallistratos (Greece), Kazuomi Kario (Japan), Vasilios Kotsis (Greece), Adi Leiba (Israel), Patricio López-Jaramillo (Colombia), Hans-Peter Marti (Norway), Terry McCormack (UK), Paolo Mulatero (Italy), Dike B. Ojji (Nigeria), Sungha Park (South Korea), Priit Pauklin (Estonia), Sabine Perl (Austria), Arman Postadzhian (Bulgaria), Aleksander Prejbisz (Poland), Venkata Ram (India), Ramiro Sanchez (Argentina), Markus Schlaich (Australia), Alta Schutte (Australia), Cristina Sierra (Spain), Sekib Sokolovic (Bosnia and Herzegovina), Jonas Spaak (Sweden), Dimitrios Terentes-Printzios (Greece), Bruno Trimarco (Italy), Thomas Unger (The Netherlands), Bert-Jan van den Born (The Netherlands), Anna Vachulova (Slovak Republic), Agostino Virdis (Italy), Jiguang Wang (China), Ulrich Wenzel (Germany), Paul Whelton (USA), Jiri Widimsky (Czech Republic), Jacek Wolf (Poland), Grégoire Wuerzner (Switzerland), Eugene Yang (USA), Yuqing Zhang (China).

Published
2023

27. Renal outcomes and blood pressure patterns in diabetic and nondiabetic individuals at high cardiovascular risk

Author

Bohm, M, Schumacher, H, Teo, K, Lonn, E, Mahfoud, F, Emrich, I, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Lehrke, M, Marx, N, Weber, M, Williams, B, Yusuf, S, Mann, J, Bohm M., Schumacher H., Teo K. K., Lonn E. M., Mahfoud F., Emrich I., Mancia G., Redon J., Schmieder R. E., Sliwa K., Lehrke M., Marx N., Weber M. A., Williams B., Yusuf S., Mann J. F. E., Bohm, M, Schumacher, H, Teo, K, Lonn, E, Mahfoud, F, Emrich, I, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Lehrke, M, Marx, N, Weber, M, Williams, B, Yusuf, S, Mann, J, Bohm M., Schumacher H., Teo K. K., Lonn E. M., Mahfoud F., Emrich I., Mancia G., Redon J., Schmieder R. E., Sliwa K., Lehrke M., Marx N., Weber M. A., Williams B., Yusuf S., and Mann J. F. E.

Abstract

Background:Diabetes and hypertension are risk factors for renal and cardiovascular outcomes. Data on the association of achieved blood pressure (BP) with renal outcomes in patients with and without diabetes are sparse. We investigated the association of achieved SBP, DBP with renal outcomes and urinary albumin excretion (UAE) in people with vascular disease.Methods:In this pooled analysis, we assessed renal outcome data from high-risk patients aged 55 years or older with a history of cardiovascular disease, 70% of whom had hypertension, randomized to The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease trials investigating telmisartan, ramipril and their combination with a median follow-up of 56 months. Standardized office BP was measured every 6 months, estimated glomerular filtration rate (eGFR) and UAE at baseline, 2 years and study end. Associations of mean achieved BP on treatment were investigated on major renal outcomes including end-stage renal disease (ESRD), decline of eGFR by at least 40%, doubling of creatinine and the composites thereof and on UAE. Analyses were by Cox regression analysis, analysis of variance and Chi2-Test. Of 30 937 patients with complete data, 19 450 patients without and 11 487 with diabetes were enrolled between 1 December 2001 and 31 July 2003 and followed until 31 July 2008. Data were pooled as the outcomes for telmisartan 80 mg/day (n = 2903) or placebo (n = 2907) for Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease and ramipril 10 mg/day (n = 8407), telmisartan 80 mg/day (n = 8386) or the combination of both (n = 8334) were similar.Results:For both those with and without diabetes, the hazard ratios for the composites ESRD or doubling of serum creatinine (707 events overall) and ESRD or 40% eGFR loss (2371 events overall) reached a nadir at achieved SBP

Published
2021

28. Cardiovascular outcomes in patients at high cardiovascular risk with previous myocardial infarction or stroke

Author

Bohm, M, Schumacher, H, Teo, K, Lonn, E, Lauder, L, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Marx, N, Weber, M, Williams, B, Yusuf, S, Mann, J, Mahfoud, F, Bohm M., Schumacher H., Teo K. K., Lonn E. M., Lauder L., Mancia G., Redon J., Schmieder R. E., Sliwa K., Marx N., Weber M. A., Williams B., Yusuf S., Mann J. F. E., Mahfoud F., Bohm, M, Schumacher, H, Teo, K, Lonn, E, Lauder, L, Mancia, G, Redon, J, Schmieder, R, Sliwa, K, Marx, N, Weber, M, Williams, B, Yusuf, S, Mann, J, Mahfoud, F, Bohm M., Schumacher H., Teo K. K., Lonn E. M., Lauder L., Mancia G., Redon J., Schmieder R. E., Sliwa K., Marx N., Weber M. A., Williams B., Yusuf S., Mann J. F. E., and Mahfoud F.

Abstract

Background:Guidelines recommend to start blood pressure (BP)-lowering drugs also according to cardiovascular risk including history of cardiovascular events. We hypothesized that in patients with a history of myocardial infarction (MI), stroke, both or none of those, the index events predict the next event and have different SBP risk associations to different cardiovascular outcomes.Design and measurements:In this pooled posthoc, nonprespecified analysis, we assessed outcome data from high-risk patients aged 55 years or older with a history of cardiovascular events or proven cardiovascular disease, randomized to the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial and to Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease Trial investigating telmisartan, ramipril and their combination with a median follow-up of 56 months. Standardized office BP was measured every 6 months. Associations of mean achieved BP on treatment were investigated on MI, stroke and cardiovascular death. We identified patients with previous MI (N = 13 487), stroke (N = 4985), both (N = 1509) or none (N = 10 956) of these index events. Analyses were done by Cox regression, analysis of variance and Chi2-test. 30 937 patients with complete data were enrolled between 1 December 2001 and 31 July 2003, and followed until 31 July 2008. Data of both trials were pooled as the outcomes were similar.Results:Patients with MI as index event had a higher risk to experience a second MI [hazard ratio 1.42 (confidence interval (CI) 1.20-1.69), P < 0.0001] compared with patients with no events but no increased risk for a stroke as a next event [hazard ratio 0.95 (CI 0.73-1.23), n.s.]. The risk was roughly doubled when they had both, MI and stroke before [hazard ratio 2.07 (CI 1.58-2.71), P < 0.0001]. Patients with a stroke history had a roughly three-fold higher likelihood to experience a second stroke [hazard ratio 2.89 (CI 2.37-3.5

Published
2021

29. European Society of Hypertension position paper on renal denervation 2021

Author

Schmieder, R, Mahfoud, F, Mancia, G, Azizi, M, Bohm, M, Dimitriadis, K, Kario, K, Kroon, A, D Lobo, M, Ott, C, Pathak, A, Persu, A, Scalise, F, Schlaich, M, Kreutz, R, Tsioufis, C, Schmieder R. E., Mahfoud F., Mancia G., Azizi M., Bohm M., Dimitriadis K., Kario K., Kroon A. A., D Lobo M., Ott C., Pathak A., Persu A., Scalise F., Schlaich M., Kreutz R., Tsioufis C., Schmieder, R, Mahfoud, F, Mancia, G, Azizi, M, Bohm, M, Dimitriadis, K, Kario, K, Kroon, A, D Lobo, M, Ott, C, Pathak, A, Persu, A, Scalise, F, Schlaich, M, Kreutz, R, Tsioufis, C, Schmieder R. E., Mahfoud F., Mancia G., Azizi M., Bohm M., Dimitriadis K., Kario K., Kroon A. A., D Lobo M., Ott C., Pathak A., Persu A., Scalise F., Schlaich M., Kreutz R., and Tsioufis C.

Abstract

This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25-30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients' perspective and preference that needs to be respected in a shared decision-making process.

Published
2021

30. NT-proBNP and stem cell factor plasma concentrations are independently associated with cardiovascular outcomes in end-stage renal disease hemodialysis patients

Author

Rossignol, P, primary, Duarte, K, additional, Bresso, E, additional, A, Åsberg, additional, Devignes, M D, additional, Eriksson, N, additional, Girerd, N, additional, Glerup, R, additional, Jardine, A G, additional, Holdaas, H, additional, Lamiral, Z, additional, Leroy, C, additional, Massy, Z, additional, März, W, additional, Krämer, B, additional, Wu, P H, additional, Schmieder, R, additional, Soveri, I, additional, Christensen, J H, additional, Svensson, M, additional, Zannad, F, additional, and Fellström, B, additional

Published
2022
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35. Basisuntersuchungen

Author

Reiter, W., Rosenthal, J., Klingbeil, A. U., Schmieder, R. E., Karasch, T., Lottermoser, K., Vetter, H., Arlart, I. P., Fischer, M., Gross, M. D., Shapiro, B., Michelson, G., Groh, M. J. M., Rosenthal, J., and Kolloch, R.

Published
2004
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41. NT-proBNP and stem cell factor plasma concentrations are independently associated with cardiovascular outcomes in end-stage renal disease hemodialysis patients

Author

Rossignol, P, Duarte, K, Bresso, E, A, Åsberg, Devignes, M D, Eriksson, N, Girerd, N, Glerup, R, Jardine, A G, Holdaas, H, Lamiral, Z, Leroy, C, Massy, Z, März, W, Krämer, B, Wu, Ping-Hsun, Schmieder, R, Soveri, Inga, Christensen, J H, Svensson, M, Zannad, F, Fellström, Bengt, Rossignol, P, Duarte, K, Bresso, E, A, Åsberg, Devignes, M D, Eriksson, N, Girerd, N, Glerup, R, Jardine, A G, Holdaas, H, Lamiral, Z, Leroy, C, Massy, Z, März, W, Krämer, B, Wu, Ping-Hsun, Schmieder, R, Soveri, Inga, Christensen, J H, Svensson, M, Zannad, F, and Fellström, Bengt

Abstract

Aimas: End-stage renal disease (ESRD) treated by chronic hemodialysis (HD) is associated with poor cardiovascular (CV) outcomes, with no available evidence-based therapeutics. A multiplexed proteomic approach may identify new pathophysiological pathways associated with CV outcomes, potentially actionable for precision medicine. Methods and Results: The AURORA trial was an international, multicentre, randomized, double-blind trial involving 2776 patients undergoing maintenance HD. Rosuvastatin vs. placebo had no significant effect on the composite primary endpoint of death from CV causes, nonfatal myocardial infarction or nonfatal stroke. We first compared CV risk-matched cases and controls (n = 410) to identify novel biomarkers using a multiplex proximity extension immunoassay (276 proteomic biomarkers assessed with OlinkTM). We replicated our findings in 200 unmatched cases and 200 controls. External validation was conducted from a multicentre real-life Danish cohort [Aarhus-Aalborg (AA), n = 331 patients] in which 92 OlinkTM biomarkers were assessed. In AURORA, only N-terminal pro-brain natriuretic peptide (NT-proBNP, positive association) and stem cell factor (SCF) (negative association) were found consistently associated with the trial's primary outcome across exploration and replication phases, independently from the baseline characteristics. Stem cell factor displayed a lower added predictive ability compared with NT-ProBNP. In the AA cohort, in multivariable analyses, BNP was found significantly associated with major CV events, while higher SCF was associated with less frequent CV deaths. Conclusions: Our findings suggest that NT-proBNP and SCF may help identify ESRD patients with respectively high and low CV risk, beyond classical clinical predictors and also point at novel pathways for prevention and treatment.

Published
2022
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44. CLINICAL EVENT REDUCTIONS IN HIGH-RISK HYPERTENSION PATIENTS TREATED WITH RENAL DENERVATION: 10-YEAR PROJECTIONS BASED ON 3-YEAR FOLLOW-UP FROM THE GLOBAL SYMPLICITY REGISTRY

Author

Esler, M, Cao, K, Lobo, M, Sharp, A, Kandzari, D, Mancia, G, Böhm, M, Schmieder, R, Pietzch, J, Sharp, ASP, Kandzari, DE, Schmieder, RE, Pietzch, JB, Esler, M, Cao, K, Lobo, M, Sharp, A, Kandzari, D, Mancia, G, Böhm, M, Schmieder, R, Pietzch, J, Sharp, ASP, Kandzari, DE, Schmieder, RE, and Pietzch, JB

Published
2022

47. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial

Author

Schlaich, M, Bellet, M, Weber, M, Danaietash, P, Bakris, G, Flack, J, Dreier, R, Sassi-Sayadi, M, Haskell, L, Narkiewicz, K, Wang, J, Reid, C, Katz, I, Ajani, A, Biswas, S, Esler, M, Elder, G, Roger, S, Colquhoun, D, Mooney, J, De Backer, T, Persu, A, Chaumont, M, Krzesinski, J, Vanabsche, T, Girard, G, Pliamm, L, Schiffrin, E, Merali, F, Dresser, G, Vallee, M, Jolly, S, Chow, S, Mu, J, Yu, J, Yuan, H, Feng, Y, Zhang, X, Xie, J, Lin, L, Soucek, M, Widimsky, J, Cifkova, R, Vaclavik, J, Ullrych, M, Lukac, M, Rychlik, I, Guldager Lauridsen, T, Kantola, I, Taurio, J, Ukkola, O, Ormezzano, O, Gosse, P, Azizi, M, Courand, P, Delsart, P, Tartiere, J, Mahfoud, F, Schmieder, R, Stegbauer, J, Lurz, P, Koziolek, M, Ott, C, Toursarkissian, N, Tsioufis, K, Kyfnidis, K, Manolis, A, Patsilinakos, S, Zebekakis, P, Karavidas, A, Denes, P, Bezzegh, K, Zsom, M, Kovacs, L, Sharabi, Y, Elias, M, Sukholutsky, I, Yosefy, C, Kenis, I, Atar, S, Volpe, M, Lorenza, M, Taddei, S, Grassi, G, Veglio, F, Son, J, Kim, J, Park, J, Lee, C, Lee, H, Raugaliene, R, Marcinkeviciene, J, Kavaliauskiene, R, Deinum, J, Kroon, A, van den Born, B, Januszewicz, A, Tykarski, A, Walczewska, J, Gaciong, Z, Wiecek, A, Chrostowska, M, Kleinrok, A, Krekora, J, Kania, G, Podrazka-Szczepaniak, A, Golawski, C, Podziewski, M, Kaczmarek, B, Skoczylas, G, Wilkolaski, A, Wozniak, I, Janik-Palazzolo, M, Rewerska, B, Konradi, A, Shvarts, Y, Pecherina, T, Nikolaev, K, Liudmila, G, Orlikova, O, Mordovin, V, Petrochenkova, N, Kamalov, G, Kosmacheva, E, Tyrenko, V, Gorbunov, V, Obrezan, A, Supryadkina, T, Ler, I, Kotenko, O, Kuzin, A, Martinez, F, Redon, J, Oliveras, A, Beltran Romero, L, Shatylo, V, Rudenko, L, Bazylevych, A, Rudyk, Y, Karpenko, O, Stanislavchuk, M, Tseluyko, V, Kushnir, M, Asanov, E, Sirenko, Y, Yagensky, A, Collier, D, Gupta, P, Webb, D, Macleod, M, Mclay, J, Peace, A, Arora, S, Buchanan, P, Harris, R, Degarmo, R, Guillen, M, Karns, A, Neutel, J, Paliwal, Y, Pettis, K, Toth, P, Wayne, J, Butcher, B, Diller, P, Oparil, S, Calhoun, D, Brautigam, D, Goldman, J, Rashidi, A, Aslam, N, Haley, W, Andrawis, N, Lang, B, Miller, R, Powell, J, Dewhurst, R, Pritchard, J, Khanna, D, Tang, D, Gabra, N, Jones, C, Scott, C, Luna, B, Mussaji, M, Bhagwat, R, Bauer, M, Mcginty, J, Nambiar, R, Sangrigoli, R, Ross Davis, W, Eaves, W, Mcgrew, F, Awad, A, Bolster, E, Scott, D, Kalirao, P, Dabel, P, Calhoun, W, Gouge, S, Warren, M, Lawrence, M, Jamal, A, El-Shahawy, M, Mercado, C, Kumar, J, Velasquez-Mieyer, P, Busch, R, Lewis, T, Rich, L, Schlaich, Markus P, Bellet, Marc, Weber, Michael A, Danaietash, Parisa, Bakris, George L, Flack, John M, Dreier, Roland F, Sassi-Sayadi, Mouna, Haskell, Lloyd P, Narkiewicz, Krzysztof, Wang, Ji-Guang, Reid, Christopher, Schlaich, Markus, Katz, Ivor, Ajani, Andrew, Biswas, Sinjini, Esler, Murray, Elder, Grahame, Roger, Simon, Colquhoun, David, Mooney, John, De Backer, Tine, Persu, Alexandre, Chaumont, Martin, Krzesinski, Jean-Marie, Vanabsche, Thomas, Girard, Ginette, Pliamm, Lew, Schiffrin, Ernesto, Merali, Fatima, Dresser, George, Vallee, Michel, Jolly, Shivinder, Chow, Stephen, Wang, Jiguang, Mu, Jianjun, Yu, Jing, Yuan, Hong, Feng, Yingqing, Zhang, Xin, Xie, Jianhong, Lin, Ling, Soucek, Miroslav, Widimsky, Jiri, Cifkova, Renata, Vaclavik, Jan, Ullrych, Martin, Lukac, Martin, Rychlik, Ivan, Guldager Lauridsen, Thomas, Kantola, Ilkka, Taurio, Jyrki, Ukkola, Olavi, Ormezzano, Olivier, Gosse, Philippe, Azizi, Michel, Courand, Pierre-Yves, Delsart, Pascal, Tartiere, Jean Michel, Mahfoud, Felix, Schmieder, Roland, Stegbauer, Johannes, Lurz, Philipp, Koziolek, Michael, Ott, Christian, Toursarkissian, Nicole, Tsioufis, Konstantinos, Kyfnidis, Konstantinos, Manolis, Athanasios, Patsilinakos, Sotirios, Zebekakis, Pantelis, Karavidas, Apostolos, Denes, Pall, Bezzegh, Katalin, Zsom, Marianna, Kovacs, Laszlo, Sharabi, Yehonatan, Elias, Mazen, Sukholutsky, Ivetta, Yosefy, Chaim, Kenis, Irina, Atar, Shaul, Volpe, Massimo, Lorenza, Muiesan Maria, Taddei, Stefano, Grassi, Guido, Veglio, Franco, Son, Jung Woo, Kim, Jang-Young, Park, Joong-Il, Lee, Chang Hoon, Lee, Hae-Young, Raugaliene, Rasa, Marcinkeviciene, Jolanta Elena, Kavaliauskiene, Roma, Deinum, Jaap, Kroon, Abraham, van den Born, Bert-Jan, Januszewicz, Andrzej, Tykarski, Andrzej, Walczewska, Jolanta, Gaciong, Zbigniew, Wiecek, Andrzej, Chrostowska, Marzena, Kleinrok, Andrzej, Krekora, Jan, Kania, Grzegorz, Podrazka-Szczepaniak, Anna, Golawski, Cezary, Podziewski, Maciej, Kaczmarek, Barbara, Skoczylas, Grzegorz, Wilkolaski, Andrzej, Wozniak, Iwona, Janik-Palazzolo, Marzena, Rewerska, Barbara, Konradi, Alexandra, Shvarts, Yuriy, Pecherina, Tamara, Nikolaev, Konstantin, Liudmila, Gapon, Orlikova, Olga, Mordovin, Viktor, Petrochenkova, Natalia, Kamalov, Gadel, Kosmacheva, Elena, Tyrenko, Vadim, Gorbunov, Vladimir, Obrezan, Andrey, Supryadkina, Tatiana, Ler, Irina, Kotenko, Oleg, Kuzin, Anatoly, Martinez, Fernando, Redon, Josep, Oliveras, Anna, Beltran Romero, Luis, Shatylo, Valerii, Rudenko, Leonid, Bazylevych, Andriiy, Rudyk, Yurii, Karpenko, Oleksandr, Stanislavchuk, Mykola, Tseluyko, Vira, Kushnir, Mykola, Asanov, Ervin, Sirenko, Yuriy, Yagensky, Andriy, Collier, David, Gupta, Pankaj, Webb, David, MacLeod, Mary, McLay, James, Peace, Aaron, Arora, Samir, Buchanan, Patricia, Harris, Robert, Degarmo, Ronald, Guillen, Mario, Karns, Adam, Neutel, Joel, Paliwal, Yogesh, Pettis, Karlton, Toth, Phillip D., Wayne, Jeffrey M., Butcher, Bain, Diller, Phillip M., Oparil, Suzanne, Calhoun, David, Brautigam, Donald, Flack, John, Goldman, Jesse M., Rashidi, Arash, Aslam, Nabeel, Haley, William, Andrawis, Nabil, Lang, Brian, Miller, Randy, Powell, James, Dewhurst, Robert, Pritchard, James, Khanna, Dinesh, Tang, Dennis, Gabra, Nashwa, Park, Jean, Jones, Conigliaro, Scott, Cranford, Luna, Blanca, Mussaji, Murtaza, Bhagwat, Ravi, Bauer, Michael, McGinty, John, Nambiar, Rajesh, Sangrigoli, Renee, Ross Davis, William, Eaves, William, McGrew, Frank, Awad, Ahmed, Bolster, Eric, Scott, David, Kalirao, Paramjit, Dabel, Pascal, Calhoun, Wesley, Gouge, Steven, Warren, Mark, Lawrence, Mary Katherine, Jamal, Aamir, El-Shahawy, Mohamed, Mercado, Carlos, Kumar, Jayant, Velasquez-Mieyer, Pedro, Busch, Robert, Lewis, Todd, Rich, Lisa, Schlaich, M, Bellet, M, Weber, M, Danaietash, P, Bakris, G, Flack, J, Dreier, R, Sassi-Sayadi, M, Haskell, L, Narkiewicz, K, Wang, J, Reid, C, Katz, I, Ajani, A, Biswas, S, Esler, M, Elder, G, Roger, S, Colquhoun, D, Mooney, J, De Backer, T, Persu, A, Chaumont, M, Krzesinski, J, Vanabsche, T, Girard, G, Pliamm, L, Schiffrin, E, Merali, F, Dresser, G, Vallee, M, Jolly, S, Chow, S, Mu, J, Yu, J, Yuan, H, Feng, Y, Zhang, X, Xie, J, Lin, L, Soucek, M, Widimsky, J, Cifkova, R, Vaclavik, J, Ullrych, M, Lukac, M, Rychlik, I, Guldager Lauridsen, T, Kantola, I, Taurio, J, Ukkola, O, Ormezzano, O, Gosse, P, Azizi, M, Courand, P, Delsart, P, Tartiere, J, Mahfoud, F, Schmieder, R, Stegbauer, J, Lurz, P, Koziolek, M, Ott, C, Toursarkissian, N, Tsioufis, K, Kyfnidis, K, Manolis, A, Patsilinakos, S, Zebekakis, P, Karavidas, A, Denes, P, Bezzegh, K, Zsom, M, Kovacs, L, Sharabi, Y, Elias, M, Sukholutsky, I, Yosefy, C, Kenis, I, Atar, S, Volpe, M, Lorenza, M, Taddei, S, Grassi, G, Veglio, F, Son, J, Kim, J, Park, J, Lee, C, Lee, H, Raugaliene, R, Marcinkeviciene, J, Kavaliauskiene, R, Deinum, J, Kroon, A, van den Born, B, Januszewicz, A, Tykarski, A, Walczewska, J, Gaciong, Z, Wiecek, A, Chrostowska, M, Kleinrok, A, Krekora, J, Kania, G, Podrazka-Szczepaniak, A, Golawski, C, Podziewski, M, Kaczmarek, B, Skoczylas, G, Wilkolaski, A, Wozniak, I, Janik-Palazzolo, M, Rewerska, B, Konradi, A, Shvarts, Y, Pecherina, T, Nikolaev, K, Liudmila, G, Orlikova, O, Mordovin, V, Petrochenkova, N, Kamalov, G, Kosmacheva, E, Tyrenko, V, Gorbunov, V, Obrezan, A, Supryadkina, T, Ler, I, Kotenko, O, Kuzin, A, Martinez, F, Redon, J, Oliveras, A, Beltran Romero, L, Shatylo, V, Rudenko, L, Bazylevych, A, Rudyk, Y, Karpenko, O, Stanislavchuk, M, Tseluyko, V, Kushnir, M, Asanov, E, Sirenko, Y, Yagensky, A, Collier, D, Gupta, P, Webb, D, Macleod, M, Mclay, J, Peace, A, Arora, S, Buchanan, P, Harris, R, Degarmo, R, Guillen, M, Karns, A, Neutel, J, Paliwal, Y, Pettis, K, Toth, P, Wayne, J, Butcher, B, Diller, P, Oparil, S, Calhoun, D, Brautigam, D, Goldman, J, Rashidi, A, Aslam, N, Haley, W, Andrawis, N, Lang, B, Miller, R, Powell, J, Dewhurst, R, Pritchard, J, Khanna, D, Tang, D, Gabra, N, Jones, C, Scott, C, Luna, B, Mussaji, M, Bhagwat, R, Bauer, M, Mcginty, J, Nambiar, R, Sangrigoli, R, Ross Davis, W, Eaves, W, Mcgrew, F, Awad, A, Bolster, E, Scott, D, Kalirao, P, Dabel, P, Calhoun, W, Gouge, S, Warren, M, Lawrence, M, Jamal, A, El-Shahawy, M, Mercado, C, Kumar, J, Velasquez-Mieyer, P, Busch, R, Lewis, T, Rich, L, Schlaich, Markus P, Bellet, Marc, Weber, Michael A, Danaietash, Parisa, Bakris, George L, Flack, John M, Dreier, Roland F, Sassi-Sayadi, Mouna, Haskell, Lloyd P, Narkiewicz, Krzysztof, Wang, Ji-Guang, Reid, Christopher, Schlaich, Markus, Katz, Ivor, Ajani, Andrew, Biswas, Sinjini, Esler, Murray, Elder, Grahame, Roger, Simon, Colquhoun, David, Mooney, John, De Backer, Tine, Persu, Alexandre, Chaumont, Martin, Krzesinski, Jean-Marie, Vanabsche, Thomas, Girard, Ginette, Pliamm, Lew, Schiffrin, Ernesto, Merali, Fatima, Dresser, George, Vallee, Michel, Jolly, Shivinder, Chow, Stephen, Wang, Jiguang, Mu, Jianjun, Yu, Jing, Yuan, Hong, Feng, Yingqing, Zhang, Xin, Xie, Jianhong, Lin, Ling, Soucek, Miroslav, Widimsky, Jiri, Cifkova, Renata, Vaclavik, Jan, Ullrych, Martin, Lukac, Martin, Rychlik, Ivan, Guldager Lauridsen, Thomas, Kantola, Ilkka, Taurio, Jyrki, Ukkola, Olavi, Ormezzano, Olivier, Gosse, Philippe, Azizi, Michel, Courand, Pierre-Yves, Delsart, Pascal, Tartiere, Jean Michel, Mahfoud, Felix, Schmieder, Roland, Stegbauer, Johannes, Lurz, Philipp, Koziolek, Michael, Ott, Christian, Toursarkissian, Nicole, Tsioufis, Konstantinos, Kyfnidis, Konstantinos, Manolis, Athanasios, Patsilinakos, Sotirios, Zebekakis, Pantelis, Karavidas, Apostolos, Denes, Pall, Bezzegh, Katalin, Zsom, Marianna, Kovacs, Laszlo, Sharabi, Yehonatan, Elias, Mazen, Sukholutsky, Ivetta, Yosefy, Chaim, Kenis, Irina, Atar, Shaul, Volpe, Massimo, Lorenza, Muiesan Maria, Taddei, Stefano, Grassi, Guido, Veglio, Franco, Son, Jung Woo, Kim, Jang-Young, Park, Joong-Il, Lee, Chang Hoon, Lee, Hae-Young, Raugaliene, Rasa, Marcinkeviciene, Jolanta Elena, Kavaliauskiene, Roma, Deinum, Jaap, Kroon, Abraham, van den Born, Bert-Jan, Januszewicz, Andrzej, Tykarski, Andrzej, Walczewska, Jolanta, Gaciong, Zbigniew, Wiecek, Andrzej, Chrostowska, Marzena, Kleinrok, Andrzej, Krekora, Jan, Kania, Grzegorz, Podrazka-Szczepaniak, Anna, Golawski, Cezary, Podziewski, Maciej, Kaczmarek, Barbara, Skoczylas, Grzegorz, Wilkolaski, Andrzej, Wozniak, Iwona, Janik-Palazzolo, Marzena, Rewerska, Barbara, Konradi, Alexandra, Shvarts, Yuriy, Pecherina, Tamara, Nikolaev, Konstantin, Liudmila, Gapon, Orlikova, Olga, Mordovin, Viktor, Petrochenkova, Natalia, Kamalov, Gadel, Kosmacheva, Elena, Tyrenko, Vadim, Gorbunov, Vladimir, Obrezan, Andrey, Supryadkina, Tatiana, Ler, Irina, Kotenko, Oleg, Kuzin, Anatoly, Martinez, Fernando, Redon, Josep, Oliveras, Anna, Beltran Romero, Luis, Shatylo, Valerii, Rudenko, Leonid, Bazylevych, Andriiy, Rudyk, Yurii, Karpenko, Oleksandr, Stanislavchuk, Mykola, Tseluyko, Vira, Kushnir, Mykola, Asanov, Ervin, Sirenko, Yuriy, Yagensky, Andriy, Collier, David, Gupta, Pankaj, Webb, David, MacLeod, Mary, McLay, James, Peace, Aaron, Arora, Samir, Buchanan, Patricia, Harris, Robert, Degarmo, Ronald, Guillen, Mario, Karns, Adam, Neutel, Joel, Paliwal, Yogesh, Pettis, Karlton, Toth, Phillip D., Wayne, Jeffrey M., Butcher, Bain, Diller, Phillip M., Oparil, Suzanne, Calhoun, David, Brautigam, Donald, Flack, John, Goldman, Jesse M., Rashidi, Arash, Aslam, Nabeel, Haley, William, Andrawis, Nabil, Lang, Brian, Miller, Randy, Powell, James, Dewhurst, Robert, Pritchard, James, Khanna, Dinesh, Tang, Dennis, Gabra, Nashwa, Park, Jean, Jones, Conigliaro, Scott, Cranford, Luna, Blanca, Mussaji, Murtaza, Bhagwat, Ravi, Bauer, Michael, McGinty, John, Nambiar, Rajesh, Sangrigoli, Renee, Ross Davis, William, Eaves, William, McGrew, Frank, Awad, Ahmed, Bolster, Eric, Scott, David, Kalirao, Paramjit, Dabel, Pascal, Calhoun, Wesley, Gouge, Steven, Warren, Mark, Lawrence, Mary Katherine, Jamal, Aamir, El-Shahawy, Mohamed, Mercado, Carlos, Kumar, Jayant, Velasquez-Mieyer, Pedro, Busch, Robert, Lewis, Todd, and Rich, Lisa

Abstract

Background: Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension. Methods: PRECISION was a multicentre, blinded, randomised, parallel-group, phase 3 study, which was done in hospitals or research centres in Europe, North America, Asia, and Australia. Patients were eligible for randomisation if their sitting systolic blood pressure was 140 mm Hg or higher despite taking standardised background therapy consisting of three antihypertensive drugs, including a diuretic. The study consisted of three sequential parts: part 1 was the 4-week double-blind, randomised, and placebo-controlled part, in which patients received aprocitentan 12·5 mg, aprocitentan 25 mg, or placebo in a 1:1:1 ratio; part 2 was a 32-week single (patient)-blind part, in which all patients received aprocitentan 25 mg; and part 3 was a 12-week double-blind, randomised, and placebo-controlled withdrawal part, in which patients were re-randomised to aprocitentan 25 mg or placebo in a 1:1 ratio. The primary and key secondary endpoints were changes in unattended office systolic blood pressure from baseline to week 4 and from withdrawal baseline to week 40, respectively. Secondary endpoints included 24-h ambulatory blood pressure changes. The study is registered on ClinicalTrials.gov, NCT03541174. Findings: The PRECISION study was done from June 18, 2018, to April 25, 2022. 1965 individuals were screened and 730 were randomly assigned. Of these 730 patients, 704 (96%) completed part 1 of the study; of these, 613 (87%) completed part 2 and, of these, 577 (94%) completed part 3 of the study. The least square m

Published
2022

48. Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium

Author

Kandzari, D, Mahfoud, F, Weber, M, Townsend, R, Parati, G, Fisher, N, Lobo, M, Bloch, M, Böhm, M, Sharp, A, Schmieder, R, Azizi, M, Schlaich, M, Papademetriou, V, Kirtane, A, Daemen, J, Pathak, A, Ukena, C, Lurz, P, Grassi, G, Myers, M, Finn, A, Morice, M, Mehran, R, Jüni, P, Stone, G, Krucoff, M, Whelton, P, Tsioufis, K, Cutlip, D, Spitzer, E, Kandzari, David E, Mahfoud, Felix, Weber, Michael A, Townsend, Raymond, Parati, Gianfranco, Fisher, Naomi D L, Lobo, Melvin D, Bloch, Michael, Böhm, Michael, Sharp, Andrew S P, Schmieder, Roland E, Azizi, Michel, Schlaich, Markus P, Papademetriou, Vasilios, Kirtane, Ajay J, Daemen, Joost, Pathak, Atul, Ukena, Christian, Lurz, Philipp, Grassi, Guido, Myers, Martin, Finn, Aloke V, Morice, Marie-Claude, Mehran, Roxana, Jüni, Peter, Stone, Gregg W, Krucoff, Mitchell W, Whelton, Paul K, Tsioufis, Konstantinos, Cutlip, Donald E, Spitzer, Ernest, Kandzari, D, Mahfoud, F, Weber, M, Townsend, R, Parati, G, Fisher, N, Lobo, M, Bloch, M, Böhm, M, Sharp, A, Schmieder, R, Azizi, M, Schlaich, M, Papademetriou, V, Kirtane, A, Daemen, J, Pathak, A, Ukena, C, Lurz, P, Grassi, G, Myers, M, Finn, A, Morice, M, Mehran, R, Jüni, P, Stone, G, Krucoff, M, Whelton, P, Tsioufis, K, Cutlip, D, Spitzer, E, Kandzari, David E, Mahfoud, Felix, Weber, Michael A, Townsend, Raymond, Parati, Gianfranco, Fisher, Naomi D L, Lobo, Melvin D, Bloch, Michael, Böhm, Michael, Sharp, Andrew S P, Schmieder, Roland E, Azizi, Michel, Schlaich, Markus P, Papademetriou, Vasilios, Kirtane, Ajay J, Daemen, Joost, Pathak, Atul, Ukena, Christian, Lurz, Philipp, Grassi, Guido, Myers, Martin, Finn, Aloke V, Morice, Marie-Claude, Mehran, Roxana, Jüni, Peter, Stone, Gregg W, Krucoff, Mitchell W, Whelton, Paul K, Tsioufis, Konstantinos, Cutlip, Donald E, and Spitzer, Ernest

Abstract

The clinical implications of hypertension in addition to a high prevalence of both uncontrolled blood pressure and medication nonadherence promote interest in developing device-based approaches to hypertension treatment. The expansion of device-based therapies and ongoing clinical trials underscores the need for consistency in trial design, conduct, and definitions of clinical study elements to permit trial comparability and data poolability. Standardizing methods of blood pressure assessment, effectiveness measures beyond blood pressure alone, and safety outcomes are paramount. The Hypertension Academic Research Consortium (HARC) document represents an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspectives on clinical trial design and methodology. The HARC document integrates the collective information among device-based therapies for hypertension to better address existing challenges and identify unmet needs for technologies proposed to treat the world's leading cause of death and disability. Consistent with the Academic Research Consortium charter, this document proposes pragmatic consensus clinical design principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies.

Published
2022

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