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53. Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure

Author

Bozkurt, Biykem, Coats, Andrew JS, Tsutsui, Hiroyuki, Abdelhamid, Magdy, Adamopoulos, Stamatis, Albert, Nancy, Anker, Stefan D., Atherton, John, Böhm, Michael, Butler, Javed, Drazner, Mark H., Felker, G. Michael, Filippatos, Gerasimos, Fonarow, Gregg C., Fiuzat, Mona, Gomez-Mesa, Juan–Esteban, Heidenreich, Paul, Imamura, Teruhiko, Januzzi, James, Jankowska, Ewa A., Khazanie, Prateeti, Kinugawa, Koichiro, Lam, Carolyn S.P., Matsue, Yuya, Metra, Marco, Ohtani, Tomohito, Francesco Piepoli, Massimo, Ponikowski, Piotr, Rosano, Giuseppe M.C., Sakata, Yasushi, SeferoviĆ, Petar, Starling, Randall C., Teerlink, John R., Vardeny, Orly, Yamamoto, Kazuhiro, Yancy, Clyde, Zhang, Jian, and Zieroth, Shelley

Published
2021
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55. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study

Author

Felker, G. Michael, McMurray, John J.V., Cleland, John G., O’Connor, Christopher M., Teerlink, John R., Voors, Adriaan A., Belohlavek, Jan, Böhm, Michael, Borentain, Maria, Bueno, Hector, Cole, Robert T., DeSouza, Mary M., Ezekowitz, Justin A., Filippatos, Gerasimos, Lang, Ninian N., Kessler, Paul D., Martinez, Felipe A., Mebazaa, Alex, Metra, Marco, Mosterd, Arend, Pang, Peter S., Ponikowski, Piotr, Sato, Naoki, Seiffert, Dietmar, and Ye, June

Published
2021
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60. Guideline-Directed Medical Therapy After Hospitalization for Acute Heart Failure: Insights From the CONNECT-HF.

Author

Satoshi Shoji, Kaltenbach, Lisa, Granger, Bradi B., Fonarow, Gregg C., Al-Khalidi, Hussein R., Albert, Nancy M., Butler, Javed, Allen, Larry A., Lanfear, David E., Thibodeau, Jennifer T., Chapman, Brittany M., Oliver-McNeil, Sandra M., Felker, G. Michael, Pina, Ileana L., Granger, Christopher B., Hernandez, Adrian F., and DeVore, Adam D.

Published
2024
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61. Centrally adjudicated vs. investigator-reported outcomes in randomized heart failure trials.

Author

Wandel, Simon, Desai, Akshay S, Chen, Chien-Wei, McMurray, John J V, Packer, Milton, Solomon, Scott D, Pfeffer, Marc A, Felker, G Michael, Zannad, Faiez, Petrie, Mark C, Jhund, Pardeep S, Attari, Zenab, Mueller-Velten, Guenther, Lefkowitz, Martin, Soergel, David, and Gimpelewicz, Claudio

Subjects
HEART failure, CARDIOVASCULAR disease related mortality, MORTALITY, DEATH rate, TREATMENT effectiveness
Abstract

Background and Aims Heart failure endpoints in cardiovascular outcome trials are commonly identified through centralized adjudication of investigator-reported events. It remains unclear whether central adjudication improves the accuracy of treatment effect estimates in terms of log[hazard ratios (HR)]. Methods Data from seven cardiovascular outcome trials with >1000 patients that included centrally adjudicated heart failure outcomes were utilized to assess (i) the concordance between investigator-reported and centrally adjudicated heart failure and cardiovascular death events; (ii) rates of subsequent all-cause mortality following positively vs. negatively adjudicated heart failure events; and (iii) the correlation of log(HR) based on centrally adjudicated vs. investigator-reported events. Results Positive adjudication rates for investigator-reported events varied widely across trials, but were generally higher for cardiovascular death (range: 87.9%–99.2%) than for heart failure hospitalization (range: 61.6%–88.0%). The risk for subsequent all-cause death was similar for positively and negatively adjudicated heart failure hospitalizations. Log(HR) correlated well for cardiovascular death [ R 2 =.80, 95% credible interval (CrI): 0.53–0.93] and the composite of cardiovascular death or heart failure hospitalization (R 2 =.79, 95% CrI: 0.46–0.93), but less for heart failure hospitalization (R 2 =.57, 95% CrI: 0.10–0.83). Conclusions Positive adjudication rates were lower for heart failure events than cardiovascular death, but even negatively adjudicated heart failure events are prognostically important. Central adjudication of events did not alter the results (precision or estimated log(HR)), though some variation was observed, depending on the indication. The results suggest that the decision to pursue centralized adjudication of heart failure events in a specific trial may need to be individualized. [ABSTRACT FROM AUTHOR]

Published
2024
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62. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2

Author

Loungani, Rahul S., Teerlink, John R., Metra, Marco, Allen, Larry A., Butler, Javed, Carson, Peter E., Chen, Chien-Wei, Cotter, Gad, Davison, Beth A., Eapen, Zubin J., Filippatos, Gerasimos S., Gimpelewicz, Claudio, Greenberg, Barry, Holbro, Thomas, Januzzi, James L., Jr., Lanfear, David E., Pang, Peter S., Piña, Ileana L., Ponikowski, Piotr, Miller, Alan B., Voors, Adriaan A., and Felker, G. Michael

Published
2020
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64. Splanchnic Nerve Block for Chronic Heart Failure

Author

Fudim, Marat, Boortz-Marx, Richard L., Ganesh, Arun, DeVore, Adam D., Patel, Chetan B., Rogers, Joseph G., Coburn, Aubrie, Johnson, Inneke, Paul, Amanda, Coyne, Brian J., Rao, Sunil V., Gutierrez, J. Antonio, Kiefer, Todd L., Kong, David F., Green, Cynthia L., Jones, W. Schuyler, Felker, G. Michael, Hernandez, Adrian F., and Patel, Manesh R.

Published
2020
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65. Endpoints in Heart Failure Drug Development: History and Future

Author

Fiuzat, Mona, Lowy, Naomi, Stockbridge, Norman, Sbolli, Marco, Latta, Federica, Lindenfeld, JoAnn, Lewis, Eldrin F., Abraham, William T., Teerlink, John, Walsh, Mary, Heidenreich, Paul, Bozkurt, Biykem, Starling, Randall C., Solomon, Scott, Felker, G. Michael, Butler, Javed, Yancy, Clyde, Stevenson, Lynne W., O'Connor, Christopher, Unger, Ellis, Temple, Robert, and McMurray, John

Published
2020
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68. Body Weight Change During and After Hospitalization for Acute Heart Failure: Patient Characteristics, Markers of Congestion, and Outcomes Findings From the ASCEND-HF Trial

Author

Ambrosy, Andrew P, Cerbin, Lukasz P, Armstrong, Paul W, Butler, Javed, Coles, Adrian, DeVore, Adam D, Dunlap, Mark E, Ezekowitz, Justin A, Felker, G Michael, Fudim, Marat, Greene, Stephen J, Hernandez, Adrian F, O'Connor, Christopher M, Schulte, Philip, Starling, Randall C, Teerlink, John R, Voors, Adriaan A, and Mentz, Robert J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Heart Disease, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Acute Disease, Aged, Dyspnea, Female, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Natriuretic Agents, Natriuretic Peptide, Brain, Treatment Outcome, Urine, Weight Gain, Weight Loss, acute heart failure, body weight, dyspnea, urine output, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

ObjectivesThis study sought to examine the relationships between in-hospital and post-discharge body weight changes and outcomes among patients hospitalized for acute heart failure (AHF).BackgroundBody weight changes during and after hospitalization for AHF and the relationships with outcomes have not been well characterized.MethodsA post hoc analysis was performed of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure) trial, which enrolled patients admitted for AHF regardless of ejection fraction. In-hospital body weight change was defined as the difference between baseline and discharge/day 10, whereas post-discharge body weight change was defined as the difference between discharge/day 10 and day 30. Spearman rank correlations of weight change, urine output (UOP), and dyspnea relief as assessed by a 7-point Likert scale are described. Logistic and Cox proportional hazards regression was used to evaluate the relationship between weight change and outcomes.ResultsStudy participants with complete body weight data (n = 4,172) had a mean age of 65 ± 14 years, and 66% were male. Ischemic heart disease was reported in 60% of patients and the average ejection fraction was 30 ± 13%. The median change in body weight was -1.0 kg (interquartile range: -2.1 to 0.0 kg) at 24 h and -2.3 kg (interquartile range: -5.0 to -0.7 kg) by discharge/day 10. At hour 24, there was a weak correlation between change in body weight and UOP (r = -0.381), and minimal correlation between body weight change and dyspnea relief (r = -0.096). After risk adjustment, increasing body weight during hospitalization was associated with a 16% increase per kg in the likelihood of 30-day mortality or HF readmission for patients showing weight loss ≤1 kg or weight gain during hospitalization (odds ratio per kg increase 1.16, 95% confidence interval [CI]: 1.09 to 1.27; p < 0.001). Among the subset of patients experiencing >1-kg increase in body weight post-discharge, increasing body weight was associated with higher risk of 180-day mortality (hazard ratio per kg increase 1.16; 95% CI: 1.09 to 1.23; p < 0.001).ConclusionsA substantial number of patients experienced minimal weight loss or frank weight gain in the context of an AHF trial, and increasing body weight in this subset of patients was independently associated with a worse post-discharge prognosis.

Published
2017

69. Sacubitril/valsartan and cardiovascular biomarkers among patients with recent COVID‐19 infection: The PARACOR‐19 randomized clinical trial

Author

Greene, Stephen J., primary, Chambers, RaKavius, additional, Lerman, Joseph B., additional, Harrington, Josephine, additional, deFilippi, Christopher R, additional, Wendell, David C., additional, Kim, Han W., additional, Green, Cynthia L., additional, Butler, Javed, additional, and Felker, G. Michael, additional

Published
2024
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70. Effects of serelaxin in acute heart failure patients with renal impairment: results from RELAX-AHF.

Author

Liu, Licette CY, Voors, Adriaan A, Teerlink, John R, Cotter, Gad, Davison, Beth A, Felker, G Michael, Filippatos, Gerasimos, Chen, Yakuan, Greenberg, Barry H, Ponikowski, Piotr, Pang, Peter S, Prescott, Margaret F, Hua, Tsushung A, Severin, Thomas M, and Metra, Marco

Subjects
Kidney, Humans, Kidney Diseases, Acute Disease, Relaxin, Recombinant Proteins, Cardiovascular Agents, Glomerular Filtration Rate, Treatment Outcome, Retrospective Studies, Time Factors, Aged, Aged, 80 and over, Middle Aged, Female, Male, Heart Failure, Randomized Controlled Trials as Topic, Kaplan-Meier Estimate, Acute heart failure, Number needed to treat, Renal function, Renal impairment, Serelaxin, and over, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology
Abstract

BackgroundSerelaxin showed beneficial effects on clinical outcome and trajectories of renal markers in patients with acute heart failure. We aimed to study the interaction between renal function and the treatment effect of serelaxin.MethodsIn the current post hoc analysis of the RELAX-AHF trial, we included all patients with available estimated glomerular filtration rate (eGFR) at baseline (n = 1132). Renal impairment was defined as an eGFR

Published
2016

72. Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF

Author

DeVore, Adam D., Granger, Bradi B., Fonarow, Gregg C., Al-Khalidi, Hussein R., Albert, Nancy M., Lewis, Eldrin F., Butler, Javed, Piña, Ileana L., Heidenreich, Paul A., Allen, Larry A., Yancy, Cyde W., Cooper, Lauren B., Felker, G. Michael, Kaltenbach, Lisa A., McRae, A. Thomas, Lanfear, David E., Harrison, Robert W., Kociol, Robb D., Disch, Maghee, Ariely, Dan, Miller, Julie M., Granger, Christopher B., and Hernandez, Adrian F.

Published
2020
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75. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil:Results From the GALACTIC-HF Study

Author

Felker, G. Michael, Solomon, Scott D., Metra, Marco, Mcmurray, John J.V., Diaz, Rafael, Claggett, Brian, Lanfear, David E., Vandekerckhove, Hans, Biering-Sørensen, Tor, Lopes, Renato D., Arias-Mendoza, Alexandra, Momomura, Shin Ichi, Corbalan, Ramon, Ramires, Felix J.A., Zannad, Faiez, Heitner, Stephen B., Divanji, Punag H., Kupfer, Stuart, Malik, Fady I., Teerlink, John R., Felker, G. Michael, Solomon, Scott D., Metra, Marco, Mcmurray, John J.V., Diaz, Rafael, Claggett, Brian, Lanfear, David E., Vandekerckhove, Hans, Biering-Sørensen, Tor, Lopes, Renato D., Arias-Mendoza, Alexandra, Momomura, Shin Ichi, Corbalan, Ramon, Ramires, Felix J.A., Zannad, Faiez, Heitner, Stephen B., Divanji, Punag H., Kupfer, Stuart, Malik, Fady I., and Teerlink, John R.

Abstract

Background: Omecamtiv mecarbil improves outcomes in patients with heart failure and reduced ejection fraction (HFrEF). We examined the relationship between baseline troponin levels, change in troponin levels over time and the treatment effect of omecamtiv mecarbil in patients enrolled in the Global Approach to Lowering Adverse Cardiac Outcomes through Improving Contractility in Heart Failure (GALACTIC-HF) trial (NCT02929329). Methods: GALACTIC-HF was a double-blind, placebo-controlled trial that randomized 8256 patients with symptomatic HFrEF to omecamtiv mecarbil or placebo. High-sensitivity troponin I (cTnI) was measured serially at a core laboratory. We analyzed the relationship between both baseline cTnI and change in cTnI concentrations with clinical outcomes and the treatment effect of omecamtiv mecarbil. Results: Higher baseline cTnI concentrations were associated with a risk of adverse outcomes (hazard ratio for the primary endpoint of time to first HF event or CV death = 1.30; 95% CI 1.28, 1.33; P < 0.001 per doubling of baseline cTnI). Although the incidence of safety outcomes was higher in patients with higher baseline cTnI, there was no difference between treatment groups. Treatment with omecamtiv mecarbil led to a modest increase in cTnI that was related to plasma concentrations of omecamtiv mecarbil, and it peaked at 6 weeks. An increase in troponin from baseline to week 6 was associated with an increased risk of the primary endpoint (P < 0.001), which was similar, regardless of treatment assignment (P value for interaction = 0.2). Conclusions: In a cohort of patients with HFrEF, baseline cTnI concentrations were strongly associated with adverse clinical outcomes. Although cTnI concentrations were higher in patients treated with omecamtiv mecarbil, we did not find a differential effect of omecamtiv mecarbil on either safety or efficacy based on baseline cTnI status or change in cTnI.

Published
2024

77. Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development

Author

Psotka, Mitchell A., Fiuzat, Mona, Carson, Peter E., Kao, David P., Cerkvenik, Jeffrey, Schaber, Daniel E., Verta, Patrick, Kazmierski, Robert T., Shinnar, Meir, Stockbridge, Norman, Unger, Ellis F., Zuckerman, Bram, Butler, Javed, Felker, G. Michael, Konstam, Marvin A., Lindenfeld, JoAnn, Solomon, Scott D., Teerlink, John R., O'Connor, Christopher M., and Abraham, William T.

Published
2019
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80. Breastfeeding, Cellular Immune Activation, and Myocardial Recovery in Peripartum Cardiomyopathy

Author

McNamara, Dennis M, Fett, James D., Pisarcik, Jessica, McTiernan, Charles, Hanley-Yanez, Karen, Gorcsan, John, III, Schelbert, Erik, Alharethi, Rami, Rasmusson, Kismet, Brunisholz, Kim, Butler, Amy, Budge, Deborah, Kfoury, A.G., Horne, Benjamin, Tuinei, Joe, Brown, Heather, Damp, Julie, Naftilan, Allen J., Russell, Jill, Freehardt, Darla, Hsich, Eileen, Oblak, Cynthia, Ewald, Greg, Whitehead, Donna, Flanagan, Jean, Platts, Anne, Elkayam, Uri, Caro, Jorge, Mullin, Stephanie, Givertz, Michael M., Anello, M. Susan, Rajagopalan, Navin, Booth, David, Sandlin, Tiffany, Wijesiri, Wendy, Cooper, Leslie T., Blauwet, Lori A., Brunner, Joann, Phelps, Mary, Kempf, Ruth, Modi, Kalgi, Norwood, Tracy, Briller, Joan, Griza, Decebal Sorin, Felker, G. Michael, Kociol, Robb, Adams, Patricia, Wells, Gretchen, Thohan, Vinay, Wesley-Farrington, Deborah, Soots, Sandra, Sheppard, Richard, Michel, Caroline, Lapointe, Nathalie, Nathaniel, Heather, Kealey, Angela, Semigran, Marc, Daher, Maureen, Boehmer, John, Silber, David, Popjes, Eric, Frey, Patricia, Nicklas, Todd, Alexis, Jeffrey, Caufield, Lori, Thornton, John W., III, Gentry, Mindy, Robinson, Vincent J.B., Sharma, Gyanendra K., Holloway, Joan, Powell, Maria, Markham, David, Drazner, Mark, Fernandez, Lynn, Zucker, Mark, Baran, David A., Gimovsky, Martin L., Hochbaum, Natalia, Patel, Bharati, Adams, Laura, Ramani, Gautam, Gottlieb, Stephen, Robinson, Shawn, Fisher, Stacy, Marshall, Joanne, Haythe, Jennifer, Mancini, Donna, Bijou, Rachel, Farr, Maryjane, Marks, Marybeth, Arango, Henry, Bozkurt, Biykem, Bolos, Mariana, Mather, Paul, Rubin, Sharon, Bonita, Raphael, Eberwine, Susan, Skopicki, Hal, Stergiopoulos, Kathleen, McCathy-Santoro, Ellen, Intravaia, Jennifer, Maas, Elizabeth, Safirstein, Jordan, Kleet, Audrey, Martinez, Nancy, Corpoin, Christine, Hesari, Donna, Chaparro, Sandra, Hudson, Laura J., Ghali, Jalal K., Injic, Zora, Wittstein, Ilan S., Koczo, Agnes, Marino, Amy, Jeyabalan, Arun, Fett, James, Blauwet, Lori, Morel, Penelope A., and McNamara, Dennis M.

Published
2019
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83. Distinct Comorbidity Clusters in Patients With Acute Heart Failure

Author

Gomez, Karla Arevalo, Tromp, Jasper, Figarska, Sylwia M., Beldhuis, Iris E., Cotter, Gad, Davison, Beth A., Felker, G. Michael, Gimpelewicz, Claudio, Greenberg, Barry H., Lam, Carolyn S.P., Voors, Adriaan A., Metra, Marco, Teerlink, John R., and van der Meer, Peter

Abstract

Multimorbidity frequently occurs in patients with acute heart failure (AHF). The co-occurrence of comorbidities often follows specific patterns.

Published
2024
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84. Early Management of Patients With Acute Heart Failure: State of the Art and Future Directions. A Consensus Document From the Society for Academic Emergency Medicine/Heart Failure Society of America Acute Heart Failure Working Group

Author

Collins, Sean, Storrow, Alan B, Albert, Nancy M, Butler, Javed, Ezekowitz, Justin, Felker, G Michael, Fermann, Gregory J, Fonarow, Gregg C, Givertz, Michael M, Hiestand, Brian, Hollander, Judd E, Lanfear, David E, Levy, Phillip D, Pang, Peter S, Peacock, W Frank, Sawyer, Douglas B, Teerlink, John R, Lenihan, Daniel J, and Group, SAEM HFSA Acute Heart Failure Working

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Emergency Care, Clinical Research, Health Services, Aging, Cardiovascular, Heart Disease, Acute Disease, Consensus, Disease Management, Emergency Medicine, Forecasting, Heart Failure, Humans, Randomized Controlled Trials as Topic, Societies, Medical, Time Factors, United States, Acute heart failure, emergency medicine, early management, SAEM/HFSA Acute Heart Failure Working Group, Cardiorespiratory Medicine and Haematology, Nursing, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Clinical sciences
Abstract

Heart failure (HF) afflicts nearly 6 million Americans, resulting in one million emergency department (ED) visits and over one million annual hospital discharges. An aging population and improved survival from cardiovascular diseases is expected to further increase HF prevalence. Emergency providers play a significant role in the management of patients with acute heart failure (AHF). It is crucial that emergency physicians and other providers involved in early management understand the latest developments in diagnostic testing, therapeutics and alternatives to hospitalization. Further, clinical trials must be conducted in the ED in order to improve the evidence base and drive optimal initial therapy for AHF. Should ongoing and future studies suggest early phenotype-driven therapy improves in-hospital and post-discharge outcomes, ED treatment decisions will need to evolve accordingly. The potential impact of future studies which incorporate risk-stratification into ED disposition decisions cannot be underestimated. Predictive instruments that identify a cohort of patients safe for ED discharge, while simultaneously addressing barriers to successful outpatient management, have the potential to significantly impact quality of life and resource expenditures.

Published
2015

85. Early management of patients with acute heart failure: state of the art and future directions--a consensus document from the SAEM/HFSA acute heart failure working group.

Author

Collins, Sean P, Storrow, Alan B, Levy, Phillip D, Albert, Nancy, Butler, Javed, Ezekowitz, Justin A, Felker, G Michael, Fermann, Gregory J, Fonarow, Gregg C, Givertz, Michael M, Hiestand, Brian, Hollander, Judd E, Lanfear, David E, Pang, Peter S, Peacock, W Frank, Sawyer, Douglas B, Teerlink, John R, and Lenihan, Daniel J

Subjects
Humans, Acute Disease, Radiography, Thoracic, Electrocardiography, Physical Examination, Patient Discharge, Risk Assessment, Consensus, Emergency Service, Hospital, Disease Management, Clinical Trials as Topic, Heart Failure, Biomarkers, Health Services, Heart Disease, Emergency Care, Clinical Research, Cardiovascular, Clinical Sciences, Public Health and Health Services, Emergency & Critical Care Medicine
Abstract

Heart failure (HF) afflicts nearly 6 million Americans, resulting in 1 million emergency department (ED) visits and over 1 million annual hospital discharges. The majority of inpatient admissions originate in the ED; thus, it is crucial that emergency physicians and other providers involved in early management understand the latest developments in diagnostic testing, therapeutics, and alternatives to hospitalization. This article discusses contemporary ED management as well as the necessary next steps for ED-based acute HF research.

Published
2015

86. The Diastolic Pulmonary Gradient Does Not Predict Survival in Patients With Pulmonary Hypertension Due to Left Heart Disease

Author

Tampakakis, Emmanouil, Leary, Peter J, Selby, Van N, De Marco, Teresa, Cappola, Thomas P, Felker, G Michael, Russell, Stuart D, Kasper, Edward K, and Tedford, Ryan J

Subjects
Clinical Research, Lung, Heart Disease, Cardiovascular, Adult, Cardiac Catheterization, Diastole, Female, Follow-Up Studies, Humans, Hypertension, Pulmonary, Kaplan-Meier Estimate, Male, Middle Aged, Prognosis, Pulmonary Wedge Pressure, Retrospective Studies, Survival Rate, United States, Vascular Resistance, Ventricular Dysfunction, Left, diastolic pulmonary gradient, pulmonary hypertension, left heart disease, survival, Cardiorespiratory Medicine and Haematology
Abstract

ObjectivesThis study sought to evaluate if diastolic pulmonary gradient (DPG) can predict survival in patients with pulmonary hypertension due to left heart disease (PH-LHD).BackgroundPatients with combined post- and pre-capillary PH-LHD have worse prognosis than those with passive pulmonary hypertension. The transpulmonary gradient (TPG) and pulmonary vascular resistance (PVR) have commonly been used to identify high-risk patients. However, these parameters have significant shortcomings and do not always correlate with pulmonary vasculature remodeling. Recently, it has been suggested that DPG may be better a marker, yet its prognostic ability in patients with cardiomyopathy has not been fully assessed.MethodsA retrospective cohort of 1,236 patients evaluated for unexplained cardiomyopathy at Johns Hopkins Hospital was studied. All patients underwent right heart catheterization and were followed until death, cardiac transplantation, or the end of the study period (mean time 4.4 years). The relationships between DPG, TPG, or PVR and survival in subjects with PH-LHD (n = 469) were evaluated with Cox proportional hazards regression and Kaplan-Meier analyses.ResultsDPG was not significantly associated with mortality (hazard ratio [HR]: 1.02, p = 0.10) in PH-LHD whereas elevated TPG and PVR predicted death (HR: 1.02, p = 0.046; and HR: 1.11, p = 0.002, respectively). Similarly, DPG did not differentiate survivors from non-survivors at any selected cut points including a DPG of 7 mm Hg.ConclusionsIn this retrospective study of patients with cardiomyopathy and PH-LHD, an elevated DPG was not associated with worse survival.

Published
2015

87. Left Ventricular Ejection Fraction and the Future of Heart Failure Phenotyping

Author

Dimond, Matthew G., primary, Ibrahim, Nasrien E., additional, Fiuzat, Mona, additional, McMurray, John J.V., additional, Lindenfeld, JoAnn, additional, Ahmad, Tariq, additional, Bozkurt, Biykem, additional, Bristow, Michael R., additional, Butler, Javed, additional, Carson, Peter E., additional, Felker, G. Michael, additional, Jessup, Mariell, additional, Murillo, Jaime, additional, Kondo, Toru, additional, Solomon, Scott D., additional, Abraham, William T., additional, O’Connor, Christopher M., additional, and Psotka, Mitchell A., additional

Published
2024
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89. Tricuspid Regurgitation and Clinical Outcomes in Heart Failure With Reduced Ejection Fraction

Author

Adamo, Marianna, primary, Metra, Marco, additional, Claggett, Brian L., additional, Miao, Zi Michael, additional, Diaz, Rafael, additional, Felker, G. Michael, additional, McMurray, John J.V., additional, Solomon, Scott D., additional, Biering-Sørensen, Tor, additional, Divanji, Punag H., additional, Heitner, Stephen B., additional, Kupfer, Stuart, additional, Malik, Fady I., additional, and Teerlink, John R., additional

Published
2024
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91. Charting a Roadmap for Heart Failure Biomarker Studies

Author

Ahmad, Tariq, Fiuzat, Mona, Pencina, Michael J, Geller, Nancy L, Zannad, Faiez, Cleland, John GF, Snider, James V, Blankenberg, Stephan, Adams, Kirkwood F, Redberg, Rita F, Kim, Jae B, Mascette, Alice, Mentz, Robert J, O'Connor, Christopher M, Felker, G Michael, and Januzzi, James L

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Heart Disease, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Biomarkers, Cooperative Behavior, Heart Failure, Humans, Prognosis, Research Design, biomarkers, heart failure, studies, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology
Abstract

Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulted in enthusiasm for their use in prognostication and selection of appropriate therapies. However, despite considerable amounts of information available on numerous biomarkers, inconsistent research methodologies and lack of clinical correlations have made bench-to-bedside translations rare and left the literature with countless publications of varied quality. There is a need for a systematic and collaborative approach aimed at definitively studying the clinical benefits of novel biomarkers. In this review, on the basis of input from academia, industry, and governmental agencies, we propose a systematized approach based on adherence to specific quality measures for studies looking to augment current prediction model or use biomarkers to tailor therapeutics. We suggest that study quality, rather than results, should determine publication and propose a system for grading biomarker studies. We outline the need for collaboration between clinical investigators and statisticians to introduce more advanced statistical methodologies into the field of biomarkers that would allow for data from a large number of variables to be distilled into clinically actionable information. Lastly, we propose the creation of a heart failure biomarker consortium that would allow for a comprehensive list of biomarkers to be concomitantly analyzed in a pooled sample of randomized clinical trials and hypotheses to be generated for testing in biomarker-guided trials. Such a consortium could collaborate in sharing samples to identify biomarkers, undertake meta-analyses on completed trials, and spearhead clinical trials to test the clinical utility of new biomarkers.

Published
2014

95. Heart Failure With Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials

Author

Parikh, Kishan S., Sharma, Kavita, Fiuzat, Mona, Surks, Howard K., George, Jyothis T., Honarpour, Narimon, Depre, Christopher, Desvigne-Nickens, Patrice, Nkulikiyinka, Richard, Lewis, Gregory D., Gomberg-Maitland, Mardi, O’Connor, Christopher M., Stockbridge, Norman, Califf, Robert M., Konstam, Marvin A., Januzzi, James L., Jr., Solomon, Scott D., Borlaug, Barry A., Shah, Sanjiv J., Redfield, Margaret M., and Felker, G. Michael

Published
2018
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98. Predictors of early dyspnoea relief in acute heart failure and the association with 30‐day outcomes: findings from ASCEND‐HF

Author

Mentz, Robert J, Hernandez, Adrian F, Stebbins, Amanda, Ezekowitz, Justin A, Felker, G Michael, Heizer, Gretchen M, Atar, Dan, Teerlink, John R, Califf, Robert M, Massie, Barry M, Hasselblad, Vic, Starling, Randall C, O'Connor, Christopher M, and Ponikowski, Piotr

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Aging, Good Health and Well Being, Acute Disease, Age Factors, Aged, Blood Pressure, Blood Urea Nitrogen, Dyspnea, Edema, Female, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Natriuretic Agents, Natriuretic Peptide, Brain, Natriuretic Peptides, Respiratory Rate, Risk Assessment, Treatment Outcome, Acute heart failure, Dyspnoea relief, Prognosis, Outcomes, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

AimsTo examine the characteristics associated with early dyspnoea relief during acute heart failure (HF) hospitalization, and its association with 30-day outcomes.Methods and resultsASCEND-HF was a randomized trial of nesiritide vs. placebo in 7141 patients hospitalized with acute HF in which dyspnoea relief at 6 h was measured on a 7-point Likert scale. Patients were classified as having early dyspnoea relief if they experienced moderate or marked dyspnoea improvement at 6 h. We analysed the clinical characteristics, geographical variation, and outcomes (mortality, mortality/HF hospitalization, and mortality/hospitalization at 30 days) associated with early dyspnoea relief. Early dyspnoea relief occurred in 2984 patients (43%). In multivariable analyses, predictors of dyspnoea relief included older age and oedema on chest radiograph; higher systolic blood pressure, respiratory rate, and natriuretic peptide level; and lower serum blood urea nitrogen (BUN), sodium, and haemoglobin (model mean C index = 0.590). Dyspnoea relief varied markedly across countries, with patients enrolled from Central Europe having the lowest risk-adjusted likelihood of improvement. Early dyspnoea relief was associated with lower risk-adjusted 30-day mortality/HF hospitalization [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.68-0.96] and mortality/hospitalization (HR 0.85; 95% CI 0.74-0.99), but similar mortality.ConclusionClinical characteristics such as respiratory rate, pulmonary oedema, renal function, and natriuretic peptide levels are associated with early dyspnoea relief, and moderate or marked improvement in dyspnoea was associated with a lower risk for 30-day outcomes.

Published
2013

100. Circulating T-Cell Subsets, Monocytes, and Natural Killer Cells in Peripartum Cardiomyopathy: Results From the Multicenter IPAC Study

Author

McNamara, Dennis M., Fett, James D., Pisarcik, Jessica, McTiernan, Charles, Hanley-Yanez, Karen, Gorcsan, John, III, Schelbert, Erik, Alharethi, Rami, Rasmusson, Kismet, Brunisholz, Kim, Butler, Amy, Budge, Deborah, Kfoury, A.G., Horne, Benjamin, Tuinei, Joe, Brown, Heather, Damp, Julie, Naftilan, Allen J., Russell, Jill, Freehardt, Darla, Hsich, Eileen, Oblak, Cynthia, Ewald, Greg, Whitehead, Donna, Flanagan, Jean, Platts, Anne, Elkayam, Uri, Caro, Jorge, Mullin, Stephanie, Givertz, Michael M., Anello, M. Susan, Rajagopalan, Navin, Booth, David, Sandlin, Tiffany, Wijesiri, Wendy, Cooper, Leslie T., Blauwet, Lori A., Brunner, Joann, Phelps, Mary, Kempf, Ruth, Modi, Kalgi, Norwood, Tracy, Briller, Joan, Griza, Decebal Sorin, Felker, G. Michael, Kociol, Robb, Adams, Patricia, Wells, Gretchen, Thohan, Vinay, Wesley-Farrington, Deborah, Soots, Sandra, Sheppard, Richard, Michel, Caroline, Lapointe, Nathalie, Nathaniel, Heather, Kealey, Angela, Semigran, Marc, Daher, Maureen, Boehmer, John, Silber, David, Popjes, Eric, Frey, Patricia, Nicklas, Todd, Alexis, Jeffrey, Caufield, Lori, Thornton, John W., III, Gentry, Mindy, Robinson, Vincent J.B., Sharma, Gyanendra K., Holloway, Joan, Powell, Maria, Markham, David, Drazner, Mark, Fernandez, Lynn, Zucker, Mark, Baran, David A., Gimovsky, Martin L., Hochbaum, Natalia, Patel, Bharati, Adams, Laura, Ramani, Gautam, Gottlieb, Stephen, Robinson, Shawn, Fisher, Stacy, Marshall, Joanne, Haythe, Jennifer, Mancini, Donna, Bijou, Rachel, Farr, Maryjane, Marks, Marybeth, Arango, Henry, Bozkurt, Biykem, Bolos, Mariana, Mather, Paul, Rubin, Sharon, Bonita, Raphael, Eberwine, Susan, Skopicki, Hal, Stergiopoulos, Kathleen, McCathy-Santoro, Ellen, Intravaia, Jennifer, Maas, Elizabeth, Safirstein, Jordan, Kleet, Audrey, Martinez, Nancy, Corpoin, Christine, Hesari, Donna, Chaparro, Sandra, Hudson, Laura J., Ghali, Jalal K., Injic, Zora, Wittstein, Ilan S., McTiernan, Charles F., Morel, Penelope, Thornton, John, Fett, James, and Halder, Indrani

Published
2018
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