1. Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation
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Azizi, Michel, Mahfoud, Felix, Weber, Michael, Sharp, Andrew, Schmieder, Roland, Lurz, Philipp, Lobo, Melvin, Fisher, Naomi, Daemen, Joost, Bloch, Michael, Basile, Jan, Sanghvi, Kintur, Saxena, Manish, Gosse, Philippe, Jenkins, J. Stephen, Levy, Terry, Persu, Alexandre, Kably, Benjamin, Claude, Lisa, Reeve-Stoffer, Helen, Mcclure, Candace, Kirtane, Ajay, Mullin, Christopher, Thackeray, Lisa, Chertow, Glenn, Kahan, Thomas, Dauerman, Harold, Ullery, Steven, Abbott, J. Dawn, Loening, Andreas, Zagoria, Ron, Costello, John, Krathan, Courtney, Lewis, Luot, Mcelvarr, Andrew, Reilly, John, Cash, Michael, Williams, Shannon, Jarvis, Maria, Fong, Pete, Laffer, Cheryl, Gainer, James, Robbins, Mark, Crook, Sherron, Maddel, Sarita, Hsi, David, Martin, Scott, Portnay, Edward, Ducey, Maryanne, Rose, Suzanne, Delmastro, Elizabeth, Bangalore, Sripal, Williams, Stephen, Cabos, Stanley, Rodriguez Alvarez, Carolina, Todoran, Thomas, Powers, Eric, Hodskins, Emily, Paladugu, Vijay, Tecklenburg, Anna, Devireddy, Chandan, Lea, Janice, Wells, Bryan, Fiebach, Amanda, Merlin, Claudia, Rader, Florian, Dohad, Suhail, Kim, Hyun-Min, Rashid, Mohammad, Abraham, Josephine, Owan, Theophilus, Abraham, Anu, Lavasani, Iran, Neilson, Hailey, Calhoun, David, Mcelderry, Thomas, Maddox, William, Oparil, Suzanne, Kinder, Sheila, Radhakrishnan, Jai, Batres, Candido, Edwards, Suzanne, Garasic, Joseph, Drachman, Doug, Zusman, Randy, Rosenfield, Kenneth, Do, Danny, Khuddus, Matheen, Zentko, Suzanne, O'Meara, James, Barb, Ilie, Foster, Abby, Boyette, Alice, Wang, Yale, Jay, Desmond, Skeik, Nedaa, Schwartz, Robert, Peterson, Rose, Goldman, Jo Anne, Goldman, Jessie, Ledley, Gary, Katof, Nancy, Potluri, Srinivasa, Biedermann, Scott, Ward, Jacquelyn, White, Megan, Mauri, Laura, Sobieszczky, Piotr, Smith, Alex, Aseltine, Laura, Stouffer, Rick, Hinderliter, Alan, Pauley, Eric, Wade, Tyrone, Zidar, David, Shishehbor, Mehdi, Effron, Barry, Costa, Marco, Semenec, Terence, Roongsritong, Chanwit, Nelson, Priscilla, Neumann, Bridget, Cohen, Debbie, Giri, Jay, Neubauer, Robin, Vo, Thu, Chugh, Atul, Huang, Pei-Hsiu, Jose, Powell, Flack, John, Fishman, Robert, Jones, Michael, Adams, Todd, Bajzer, Christopher, Mathur, Anthony, Jain, Ajay, Balawon, Armida, Zongo, Olivier, Bent, Clare, Beckett, David, Lakeman, Nicki, Kennard, Sarah, D’souza, Richard, Statton, Sarah, Wilkes, Lindsay, Anning, Christine, Sayer, Jeremy, Iyer, Sudha Ganesh, Robinson, Nicholas, Sevillano, Annaliza, Ocampo, Madelaine, Gerber, Robert, Faris, Mohamad, Marshall, Andrew John, Sinclair, Janet, Pepper, Hayley, Davies, Justin, Chapman, Neil, Burak, Paula, Carvelli, Paula, Jadhav, Sachin, Quinn, Jane, Rump, Lars Christian, Stegbauer, Johannes, Schimmöller, Lars, Potthoff, Sebastian, Schmid, Claudia, Roeder, Sylvia, Weil, Joachim, Hafer, Lukas, Agdirlioglu, Tolga, Köllner, Tanja, Böhm, Michael, Ewen, Sebastian, Kulenthiran, Saarraaken, Wachter, Angelika, Koch, Christina, Fengler, Karl, Rommel, Karl-Philipp, Trautmann, Kai, Petzold, Martin, Ott, Christian, Schmid, Axel, Uder, Michael, Heinritz, Ulrike, Fröhlich-Endres, Kerstin, Genth-Zotz, Sabine, Kämpfner, Denise, Grawe, Armin, Höhne, Johannes, Kaesberger, Bärbel, von Zur Mühlen, Constantin, Wolf, Dennis, Welzel, Markus, Heinrichs, Gudrun, Trabitzsch, Barbara, Cremer, Antoine, Trillaud, Hervé, Papadopoulos, Panteleimon, Maire, Florent, Gaudissard, Julie, Sapoval, Marc, Livrozet, Marine, Lorthioir, Aurélien, Amar, Laurence, Paquet, Valérie, Pathak, Atul, Honton, Benjamin, Cottin, Marianne, Petit, Frédéric, Lantelme, Pierre, Berge, Constance, Courand, Pierre-Yves, Langevin, Fatou, Delsart, Pascal, Longere, Benjamin, Ledieu, Guillaume, Pontana, François, Sommeville, Coralie, Bertrand, Fabien, Feyz, Lida, Zeijen, Victor, Ruiter, Arno, Huysken, Elisabeth, Blankestijn, Peter, Voskuil, Michiel, Rittersma, Zwaantina, Dolmans, Helma, Kroon, A.A., van Zwam, W.H., Vranken, Jeannique, de Haan., Claudia, Renkin, Jean, Maes, Frédéric, Beauloye, Christophe, Lengelé, Jean-Philippe, Huyberechts, Dominique, Bouvie, Anne, Witkowski, Adam, Januszewicz, Andrzej, Kądziela, Jacek, Prejbisj, Aleksander, Hering, Dagmara, Ciecwierz, Dariusz, Jaguszewski, Milosz, Owczuk, Radoslaw, CIC - HEGP (CIC 1418), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CArdiovasculaire Rénal Transplantation nEurovasculaire [Paris] (DMU CARTE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Saarland University [Saarbrücken], Biotechnologie et signalisation cellulaire (BSC), Université de Strasbourg (UNISTRA)-Institut de recherche de l'Ecole de biotechnologie de Strasbourg (IREBS)-Centre National de la Recherche Scientifique (CNRS), University Hospital of Wales (UHW), University of Exeter, Universitätsklinikum Erlangen [Erlangen], Leipzig University, Queen Mary University of London (QMUL), Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), Erasmus University Medical Center [Rotterdam] (Erasmus MC), University of Nevada [Reno], Medical University of South Carolina [Charleston] (MUSC), Hôpital Saint-André, Royal Bournemouth Hospital, Université Catholique de Louvain = Catholic University of Louvain (UCL), Cliniques Universitaires Saint-Luc [Bruxelles], Plant Health Institute of Montpellier (UMR PHIM), Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Institut de Recherche pour le Développement (IRD)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut Agro Montpellier, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Université de Montpellier (UM), Columbia University Medical Center (CUMC), Columbia University [New York], Danderyds sjukhus = Danderyd University Hospital, University of Vermont [Burlington], Stanford University, Argolyn Bioscience, Inc., and Argolyn Bioscience
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[SDV]Life Sciences [q-bio] - Abstract
Auteurs : RADIANCE-HTN Investigators; International audience; Importance Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m 2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m 2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of −2.4 [16.6] vs −7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. Conclusions and Relevance In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. Trial Registration ClinicalTrials.gov Identifier: NCT02649426
- Published
- 2022
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