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1. Sacubitril/valsartan compared to ramipril in high‐risk post‐myocardial infarction patients stratified according to use of mineralocorticoid receptor antagonists: insight from the PARADISE MI trial

Author

Schou, Morten, primary, Claggett, Brian, additional, Miao, Zi Michael, additional, Fernandez, Alberto, additional, Filippatos, Gerasimos, additional, Granger, Christopher, additional, Jering, Karola, additional, Maggioni, Aldo P., additional, McCausland, Finnian, additional, Villota, Julio Nuñez, additional, Rouleau, Jean‐Lucien, additional, Mody, Freny Vaghaiwalla, additional, van der Meer, Peter, additional, Vinereanu, Dragos, additional, McGrath, Martina, additional, Zhou, Yinong, additional, Mann, Douglas L., additional, Solomon, Scott D., additional, Steg, Philippe Gabriel, additional, Braunwald, Eugene, additional, McMurray, John J.V., additional, Pfeffer, Marc A., additional, and Køber, Lars, additional

Published
2023
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2. Heart failure with preserved ejection fraction, red cell distribution width, and sacubitril/valsartan

Author

Butt, Jawad H., primary, McDowell, Kirsty, additional, Kondo, Toru, additional, Desai, Akshay S., additional, Lefkowitz, Martin P., additional, Packer, Milton, additional, Petrie, Mark C., additional, Pfeffer, Marc A., additional, Rouleau, Jean L., additional, Vaduganathan, Muthiah, additional, Zile, Michael R., additional, Jhund, Pardeep S., additional, Køber, Lars, additional, Solomon, Scott, additional, and McMurray, John J.V., additional

Published
2023
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4. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure

Author

Vaduganathan, Muthiah, Ferreira, João Pedro, Rossignol, Patrick, Neuen, Brendon, Claggett, Brian L., Pfeffer, Marc A., McMurray, John J.V., Pitt, Bertram, Zannad, Faiez, Solomon, Scott D., BOZEC, Erwan, Brigham and Women's Hospital [Boston], Harvard Medical School [Boston] (HMS), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], Universidade do Porto = University of Porto, Centre Hospitalier Princesse Grace, University of New South Wales [Sydney] (UNSW), The George Institute for Global Health [Sydney] (GIGH), The University of Sydney, University of Glasgow, University of Michigan Medical School [Ann Arbor], University of Michigan [Ann Arbor], and University of Michigan System-University of Michigan System

Subjects
Heart Failure, Stroke Volume, Outcomes, Spironolactone, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Clinical trials, Kidney function, Double-Blind Method, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Mineralocorticoids, Humans, Cardiology and Cardiovascular Medicine, Glomerular Filtration Rate, Mineralocorticoid Receptor Antagonists
Abstract

Steroidal mineralocorticoid receptor antagonists (MRAs) form a cornerstone of the management of heart failure (HF), but little is known about the long-term effects of MRA therapy on kidney function. We evaluated acute and chronic estimated glomerular function (eGFR) slopes in the two largest completed trials testing steroidal MRAs in chronic HF.We conducted parallel post hoc eGFR slope analyses in two multinational, double-blind randomized, placebo-controlled trials of steroidal MRAs in chronic HF with reduced ejection fraction (EMPHASIS-HF) and preserved ejection fraction (TOPCAT Americas region). GFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation. Annual slopes of eGFR were assessed by generalized random coefficient models. Least square mean differences in eGFR slopes between steroidal MRA and placebo arms were assessed. Median follow-up was 1.8 years (EMPHASIS-HF) and 3.3 years (TOPCAT Americas). From baseline to month 4-6 ('acute eGFR slope'), compared to placebo, MRA treatment led to an acute decline in eGFR of -2.4 ml/min/1.73 msup2/sup(95% confidence interval [CI] -3.4 to -1.4; p lt; 0.001) and -2.0 ml/min/1.73 msup2/sup(95% CI -3.0 to -1.8; p lt; 0.001) in EMPHASIS-HF and TOPCAT Americas, respectively. From month 4-6 to end of study, there was no difference in 'chronic eGFR slope' between MRA and placebo arms (-0.3 ml/min/1.73 msup2/sup/year [95% CI -1.3 to 0.7; p = 0.53] and 0.1 ml/min/1.73 msup2/sup/year [95% CI -1.4 to 1.7; p = 0.86]) in EMPHASIS-HF and TOPCAT Americas, respectively.Steroidal MRAs result in acute declines in eGFR but do not modify long-term kidney disease trajectories in chronic HF with reduced or preserved ejection fraction.EMPHASIS-HF (ClinicalTrials.gov NCT00232180) and TOPCAT (ClinicalTrials.gov NCT00094302).

Published
2022

5. Geographic Differences in Patients With Acute Myocardial Infarction in The PARADISE‐MI Trial

Author

Butt, Jawad H, primary, Claggett, Brian L, additional, Miao, Zi M, additional, Jering, Karola S, additional, Sim, David, additional, van der Meer, Peter, additional, Ntsekhe, Mpiko, additional, Amir, Offer, additional, Cho, Myeong‐Chan, additional, Carrillo‐Calvillo, Jorge, additional, Núñez, Julio E, additional, Cadena, Alberto, additional, Kerkar, Prafulla, additional, Maggioni, Aldo P, additional, Steg, Philippe G, additional, Granger, Christopher B, additional, Mann, Douglas L, additional, Merkely, Béla, additional, Lewis, Eldrin F, additional, Solomon, Scott D, additional, Zhou, Yinong, additional, Køber, Lars, additional, Braunwald, Eugene, additional, McMurray, John JV, additional, and Pfeffer, Marc A, additional

Published
2023
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6. Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial

Author

Gerstein, Hertzel C., primary, Wolsk, Emil, additional, Claggett, Brian, additional, Diaz, Rafael, additional, Dickstein, Kenneth, additional, Hess, Sibylle, additional, Køber, Lars, additional, Maggioni, Aldo P., additional, McMurray, John J. V., additional, Probstfield, Jeffrey L., additional, Riddle, Matthew C., additional, Tardif, Jean‐Claude, additional, and Pfeffer, Marc A., additional

Published
2023
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7. Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure

Author

Tardif, Jean‐Claude, primary, Rouleau, Jean, additional, Chertow, Glenn M., additional, Al‐Shurbaji, Ayman, additional, Lisovskaja, Vera, additional, Gustavson, Stephanie, additional, Zhao, Yanli, additional, Bouabdallaoui, Nadia, additional, Desai, Akshay S., additional, Chernyavskiy, Alexander, additional, Evsina, Maria, additional, Merkely, Béla, additional, McMurray, John J.V., additional, and Pfeffer, Marc A., additional

Published
2022
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8. Health‐related quality of life outcomes in PARAGON‐HF

Author

Chandra, Alvin, primary, Polanczyk, Carisi A., additional, Claggett, Brian L., additional, Vaduganathan, Muthiah, additional, Packer, Milton, additional, Lefkowitz, Martin P., additional, Rouleau, Jean L., additional, Liu, Jiankang, additional, Shi, Victor C., additional, Schwende, Heike, additional, Zile, Michael R., additional, Desai, Akshay S., additional, Pfeffer, Marc A., additional, McMurray, John J.V., additional, Solomon, Scott D., additional, and Lewis, Eldrin F., additional

Published
2022
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9. Spironolactone effect on cardiac structure and function of patients with heart failure and preserved ejection fraction: a pooled analysis of three randomized trials

Author

Ferreira, João Pedro, primary, Cleland, John G., additional, Girerd, Nicolas, additional, Bozec, Erwan, additional, Rossignol, Patrick, additional, Pellicori, Pierpaolo, additional, Cosmi, Franco, additional, Mariottoni, Beatrice, additional, Solomon, Scott D., additional, Pitt, Bertram, additional, Pfeffer, Marc A., additional, Shah, Amil M., additional, Petutschnigg, Johannes, additional, Pieske, Burkert, additional, Edelmann, Frank, additional, and Zannad, Faiez, additional

Published
2022
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11. Sacubitril/valsartan versus ramipril for patients with acute myocardial infarction: win‐ratio analysis of the PARADISE‐MI trial

Author

Berwanger, Otavio, primary, Pfeffer, Marc, additional, Claggett, Brian, additional, Jering, Karola S., additional, Maggioni, Aldo P., additional, Steg, Philippe Gabriel, additional, Mehran, Roxana, additional, Lewis, Eldrin F., additional, Zhou, Yinong, additional, van der Meer, Peter, additional, De Pasquale, Carmine, additional, Merkely, Béla, additional, Filippatos, Gerasimos, additional, McMurray, John J.V., additional, Granger, Christopher B., additional, Solomon, Scott D., additional, and Braunwald, Eugene, additional

Published
2022
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12. Longitudinal trajectories in renal function before and after heart failure hospitalization among patients with heart failure with preserved ejection fraction in the PARAGON‐HF trial

Author

Chatur, Safia, primary, Vaduganathan, Muthiah, additional, Peikert, Alexander, additional, Claggett, Brian L., additional, McCausland, Finnian R., additional, Skali, Hicham, additional, Pfeffer, Marc A., additional, Beldhuis, Iris E., additional, Kober, Lars, additional, Seferovic, Petar, additional, Lefkowitz, Martin, additional, McMurray, John J.V., additional, and Solomon, Scott D., additional

Published
2022
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13. Longitudinal trajectories in renal function before and after heart failure hospitalization among patients with HFpEF in the PARAGON‐HF trial

Author

Chatur, Safia, Vaduganathan, Muthiah, Peikert, Alexander, Claggett, Brian L, McCausland, Finnian R., Skali, Hicham, Pfeffer, Marc A., Beldhuis, Iris E, Kober, Lars, Seferovic, Petar, Lefkowitz, Martin, McMurray, John J.V., and Solomon, Scott D.

Abstract

Aims: \ud Worsening renal function may impact long-term outcomes in heart failure (HF). However, little is known about the longitudinal trajectories in renal function in relation to the HF hospitalization or how this high-risk clinical event impacts renal outcomes.\ud \ud Methods and Results: \ud In PARAGON-HF, we evaluated the association between recency of prior HF hospitalization (occurring pre-randomization) and subsequent first renal composite outcome: (1) time to ≥50% decline in eGFR ; (2) development of end stage renal disease (ESRD); or (3) death attributable to renal causes. 2,306 (48.1%) patients had a history of prior HF hospitalization. Incident rates of the renal outcome were highest in those most recently hospitalized and decreased with longer time from last hospitalization. Treatment effect on the renal outcome of sacubitril/valsartan vs. valsartan was similar between patients with (HR 0.43; 95% CI: 0.26 to 0.75) and without (HR 0.63; 95% CI: 0.33 to 1.18; Pinteraction = 0.39) a prior history of HF hospitalization and appeared consistent regardless of timing of prior hospitalization for HF (Pinteraction =0.39). Serial eGFR measurements leading up to and after a HF hospitalization (occurring during the study period) and estimated eGFR trajectories using repeated measures regression models with restricted cubic splines were also examined. Patients experiencing a post-randomization HF hospitalization had a significant decline in eGFR prior to hospitalization while patients without HF hospitalization experienced a relatively stable eGFR trajectory (p

Published
2022

14. Diabetes and pre‐diabetes in patients with heart failure and preserved ejection fraction

Author

Jackson, Alice M., Rørth, Rasmus, Liu, Jiankang, Kristensen, Søren Lund, Anand, Inder S., Claggett, Brian L., Cleland, John G.F., Chopra, Vijay K., Desai, Akshay S., Ge, Junbo, Gong, Jianjian, Lam, Carolyn S.P., Lefkowitz, Martin P., Maggioni, Aldo P., Martinez, Felipe, Packer, Milton, Pfeffer, Marc A., Pieske, Burkert, Redfield, Margaret M., Rizkala, Adel R., Rouleau, Jean L., Seferović, Petar M., Tromp, Jasper, Van Veldhuisen, Dirk J., Yilmaz, Mehmet B., Zannad, Faiez, Zile, Michael R., Køber, Lars, Petrie, Mark C., Jhund, Pardeep S., Solomon, Scott D., and McMurray, John J.V.

Subjects
R1
Abstract

Aim:\ud There is an association between heart failure with preserved ejection fraction (HFpEF) and insulin resistance, but less is known about the diabetic continuum, and in particular about pre-diabetes, in HFpEF. We examined characteristics and outcomes of participants with diabetes or pre-diabetes in PARAGON-HF.\ud \ud Methods and results:\ud Patients aged ≥50 years with left ventricular ejection fraction ≥45%, structural heart disease and elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) were eligible. Patients were classified according to glycated haemoglobin (HbA1c): (i) normal HbA1c

Published
2022

15. Effects of sacubitril/valsartan versus valsartan on renal function in patients with and without diabetes and heart failure with preserved ejection fraction: insights from PARAGON‐HF

Author

Peikert, Alexander, primary, Vaduganathan, Muthiah, additional, Mc Causland, Finnian, additional, Claggett, Brian L., additional, Chatur, Safia, additional, Packer, Milton, additional, Pfeffer, Marc A., additional, Zannad, Faiez, additional, Lefkowitz, Martin P., additional, Pieske, Burkert, additional, Düngen, Hans‐Dirk, additional, McMurray, John J.V., additional, and Solomon, Scott D., additional

Published
2022
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16. Natriuretic peptide‐based inclusion criteria in heart failure with preserved ejection fraction clinical trials: insights from PARAGON‐HF

Author

Pabón, Maria A., primary, Cunningham, Jonathan W., additional, Claggett, Brian L., additional, Packer, Milton, additional, Zile, Michael, additional, Pfeffer, Marc A., additional, Lefkowitz, Martin, additional, Shi, Victor, additional, Rizkala, Adel, additional, McMurray, John J.V., additional, Solomon, Scott D., additional, and Vaduganathan, Muthiah, additional

Published
2022
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17. Angiotensin‐neprilysin inhibition and renal outcomes across the spectrum of ejection fraction in heart failure

Author

Mc Causland, Finnian R., Lefkowitz, Martin P., Claggett, Brian, Packer, Milton, Senni, Michele, Gori, Mauro, Jhund, Pardeep S., McGrath, Martina M., Rouleau, Jean L., Shi, Victor, Swedberg, Karl, Vaduganathan, Muthiah, Zannad, Faiez, Pfeffer, Marc A., Zile, Michael, McMurray, John J. V., and Solomon, Scott D.

Abstract

Aims:\ud Patients with heart failure are at higher risk of progression to end-stage renal disease (ESRD), regardless of ejection fraction (EF). We assessed the renal effects of angiotensin–neprilysin inhibition in a pooled analysis of 13 195 patients with heart failure with reduced and preserved EF.\ud \ud Methods and results:\ud We combined data from PARADIGM-HF (EF ≤40%; n = 8399) and PARAGON-HF (EF ≥45%; n = 4796) in a pre-specified pooled analysis. We assessed the effect of treatment (sacubitril/valsartan vs. enalapril or valsartan) on a composite of either ≥50% reduction in estimated glomerular filtration rate (eGFR), ESRD, or death from renal causes, in addition to changes in eGFR slope. We assessed whether baseline renal function or EF modified the effect of therapy on renal outcomes. At randomization, eGFR was 68 ± 20 ml/min/1.73 m2 in PARADIGM-HF and 63 ± 19 ml/min/1.73 m2 in PARAGON-HF. The composite renal outcome occurred in 70 of 6594 patients (1.1%) in the sacubitril/valsartan group and in 123 of 6601 patients (1.9%) in the valsartan or enalapril group (hazard ratio 0.56, 95% confidence interval [CI] 0.42–0.75; p

Published
2022

18. Influence of study discontinuation during the run‐in period on the estimated efficacy of sacubitril/valsartan in the PARAGON‐HF trial

Author

Suzuki, Kota, Claggett, Brian, Minamisawa, Masatoshi, Packer, Milton, Zile, Michael R., Pfeffer, Marc A., Chiang, Lu‐May, Lefkowitz, Martin, McMurray, John J.V., Solomon, Scott D., and Desai, Akshay S.

Abstract

Aims: \ud The 4822 patients randomized in the PARAGON-HF trial were a subset of 5746 initially eligible patients who entered sequential run-in periods. We identified patient factors associated with study discontinuation during the run-in period and estimated the implications of these discontinuations for the overall study result.\ud \ud Methods and Results: \ud We utilized multivariable logistic regression models to identify patient factors associated with study discontinuation during the run-in. The efficacy of sacubitril/valsartan in a broader cohort approximating the full run-in population was estimated by weighting randomized patients according to the inverse probability of run-in completion. A total of 924 (16.1%) subjects failed to complete the run-in period. In multivariable models, noncompletion was associated with region other than Central Europe, lower systolic blood pressure, lower serum sodium, lower hemoglobin, lower estimated glomerular filtration rate, higher NT-proBNP, higher NYHA functional class, prior HF hospitalization, and lack of prior use of renin-angiotensin system inhibitors or beta-blocker. In repeat analysis of the effect of randomized treatment in PARAGON-HF giving greater weight to participants resembling those who failed to complete the run-in period, the incidence of HF hospitalizations and cardiovascular death was higher, and sacubitril/valsartan treatment reduced the composite of total HF hospitalizations and cardiovascular death compared with valsartan (rate ratio, 0.86; 95% confidence interval, 0.74–1.00).\ud \ud Conclusion: \ud Patients with more advanced heart failure were at higher risk for noncompletion of the run-in period in PARAGON-HF. Reanalysis of study outcomes accounting for the effect of run-in noncompletion did not alter the estimated treatment effects of sacubitril/valsartan vs valsartan.

Published
2021

20. Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE‐MI): design and baseline characteristics

Author

Jering, Karola S., primary, Claggett, Brian, additional, Pfeffer, Marc A., additional, Granger, Christopher, additional, Køber, Lars, additional, Lewis, Eldrin F., additional, Maggioni, Aldo P., additional, Mann, Douglas, additional, McMurray, John J.V., additional, Rouleau, Jean‐Lucien, additional, Solomon, Scott D., additional, Steg, Philippe G., additional, van der Meer, Peter, additional, Wernsing, Margaret, additional, Carter, Katherine, additional, Guo, Weinong, additional, Zhou, Yinong, additional, Lefkowitz, Martin, additional, Gong, Jianjian, additional, Wang, Yi, additional, Merkely, Bela, additional, Macin, Stella M., additional, Shah, Urmil, additional, Nicolau, Jose C., additional, and Braunwald, Eugene, additional

Published
2021
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21. Serum potassium and outcomes in heart failure with preserved ejection fraction: a post‐hoc analysis of the PARAGON‐HF trial

Author

Ferreira, João Pedro, primary, Claggett, Brian L., additional, Liu, Jiankang, additional, Desai, Akshay S., additional, Pfeffer, Marc A., additional, Anand, Inder S., additional, van Veldhuisen, Dirk J., additional, Kober, Lars, additional, Cleland, John G.F., additional, Rouleau, Jean L., additional, Packer, Milton, additional, Zile, Michael R., additional, Shi, Victor C., additional, Lefkowitz, Martin P., additional, Shah, Sanjiv J., additional, Vardeny, Orly, additional, Zannad, Faiez, additional, Solomon, Scott D., additional, and McMurray, John J.V., additional

Published
2021
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22. Impact of diabetes on serum biomarkers in heart failure with preserved ejection fraction: insights from the TOPCAT trial

Author

De Marco, Corrado, primary, Claggett, Brian L., additional, Denus, Simon, additional, Zile, Michael R., additional, Huynh, Thao, additional, Desai, Akshay S., additional, Sirois, Martin G., additional, Solomon, Scott D., additional, Pitt, Bertram, additional, Rouleau, Jean L., additional, Pfeffer, Marc A., additional, and O'Meara, Eileen, additional

Published
2021
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23. Serum uric acid, influence of sacubitril–valsartan, and cardiovascular outcomes in heart failure with preserved ejection fraction: PARAGON‐HF

Author

Selvaraj, Senthil, primary, Claggett, Brian L., additional, Pfeffer, Marc A., additional, Desai, Akshay S., additional, Mc Causland, Finnian R., additional, McGrath, Martina M., additional, Anand, Inder S., additional, Veldhuisen, Dirk J., additional, Kober, Lars, additional, Janssens, Stefan, additional, Cleland, John G.F., additional, Pieske, Burkert, additional, Rouleau, Jean L., additional, Zile, Michael R., additional, Shi, Victor C., additional, Lefkowitz, Martin P., additional, McMurray, John J.V., additional, and Solomon, Scott D., additional

Published
2020
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26. Predictors of sudden cardiac death in high‐risk patients following a myocardial infarction

Author

Docherty, Kieran F., primary, Ferreira, João Pedro, additional, Sharma, Abhinav, additional, Girerd, Nicolas, additional, Gregson, John, additional, Duarte, Kevin, additional, Petrie, Mark C., additional, Jhund, Pardeep S., additional, Dickstein, Kenneth, additional, Pfeffer, Marc A., additional, Pitt, Bertram, additional, Rossignol, Patrick, additional, Zannad, Faiez, additional, and McMurray, John J.V., additional

Published
2020
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27. A trial to evaluate the effect of the sodium–glucose co‐transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA‐HF)

Author

McMurray, John J.V., DeMets, David L., Inzucchi, Silvio E., Køber, Lars, Kosiborod, Mikhail N., Langkilde, Anna M., Martinez, Felipe A., Bengtsson, Olof, Ponikowski, Piotr, Sabatine, Marc S., Sjöstrand, Mikaela, Solomon, Scott D., Diez, Mirta, Nicolau, Jose, Katova, Tzvetana, O'Meara, Eileen, Howlett, Jonathan, Verma, Subodh, Ge, Junbo, Belohlavek, Jan, Schou, Morten, Böhm, Michael, Merkely, Bela, Chopra, Vijay, Kitakaze, Masafumi, de Boer, Rudolf A., Drozdz, Jaroslaw, Tereshchenko, Sergey, Dukat, Andrej, Ljungman, Charlotta, Chiang, Chern‐En, Petrie, Mark, Desai, Akshay, Anand, Inder, Pham, Vinh Nguyen, Pfeffer, Marc A., Pocock, Stuart, Swedberg, Karl, Rouleau, Jean L., Chaturvedi, Nishi, Ivanovich, Peter, Levey, Andrew S., Christ‐Schmidt, Heidi, Held, Claes, Varenhorst, Christoph, Christersson, Christina, Mann, Johannes, Holmgren, Pernilla, Hallberg, Theresa, Langkilde, AnnaMaria, Denison, Hans, Reicher, Barry, Fox, Ywonne, Forsby, Mikael, Alenhag, Eva‐Lena, Nilsson, Ann, Kazanowska, Kinga, Olofsson, Eva Lavik, Karup, Cathrine, Ekedahl‐Berggren, Maria, Klockargård, Anna‐Lena, Kempe, Karin, and Selvén, Mathilda

Abstract

Background:\ud Sodium–glucose co‐transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown.\ud \ud Design and methods:\ud The Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure trial (DAPA‐HF) is an international, multicentre, parallel group, randomized, double‐blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N‐terminal pro B‐type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2. The trial is event‐driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient‐reported outcomes. A total of 4744 patients have been randomized.\ud \ud Conclusions:\ud DAPA‐HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.

Published
2019

28. Heart failure with mid-range ejection fraction in CHARM: characteristics, outcomes and effect of candesartan across the entire ejection fraction spectrum

Author

Lund, Lars H., Claggett, Brian, Liu, Jiankang, Lam, Carolyn S., Jhund, Pardeep S., Rosano, Giuseppe M., Swedberg, Karl, Yusuf, Salim, Granger, Christopher B., Pfeffer, Marc A., McMurray, John J.V., and Solomon, Scott D.

Subjects
Mid‐range ejection fraction, Candesartan, Randomized controlled trial, Heart failure, Outcomes, Preserved ejection fraction, Angiotensin receptor blocker
Abstract

Aims: \ud We tested the hypothesis that candesartan improves outcomes in heart failure (HF) with mid-range ejection fraction [HFmrEF; ejection fraction (EF) 40–49%].\ud \ud Methods and results: \ud In 7598 patients enrolled in the CHARM Programme (HF across the spectrum of EF), we assessed characteristics, outcomes and treatment effect of candesartan according to EF. Patients with HFmrEF (n = 1322, 17%) were similar to those with HF with reduced EF (HFrEF; n = 4323, 57%) with respect to some characteristics, and intermediate between HFrEF and HF with preserved EF (HFpEF; n = 1953, 26%) with respect to others. Over a mean follow-up of 2.9 years, the incidence rates for the primary outcome of cardiovascular death or HF hospitalization were 15.9, 8.5 and 8.9 per 100 patient-years in HFrEF, HFmrEF and HFpEF. In adjusted analyses, the rates of the primary outcome declined with increasing EF up to 50%. For treatment effect, the incidence rates for the primary outcome for candesartan vs. placebo were 14.4 vs. 17.5 per 100 patient-years in HFrEF [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.75–0.91; P

Published
2018

29. Prevalence and prognostic importance of precipitating factors leading to heart failure hospitalization: recurrent hospitalizations and mortality

Author

Platz, Elke, Jhund, Pardeep S., Claggett, Brian L., Pfeffer, Marc A., Swedberg, Karl, Granger, Christopher B., Yusuf, Salim, Solomon, Scott D., and McMurray, John J.

Abstract

Aims:\ud \ud Hospitalizations for heart failure (HF) are common and are associated with significant morbidity, mortality and cost. However, precipitating factors leading to HF hospitalization and their importance with respect to subsequent outcomes are not well understood.\ud Methods and results:\ud \ud The symptoms and signs present at admission and investigator-identified factors thought to have contributed to the first adjudicated HF hospitalization in the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) programme were prospectively collected and stratified by ejection fraction (EF). Potential precipitants were collected using a specifically designed case report form and categorized according to the presence of cardiovascular (CV), non-CV and unknown factors. Associations between these factors and subsequent rehospitalization and mortality rates were examined. Of 1668 patients who experienced HF hospitalization, 1152 had reduced EF (≤40%) (HFrEF) and 516 had preserved EF (HFpEF). Overall, 54% had CV, 32% had non-CV and 14% had unknown factors thought to have precipitated HF, with similar proportions in the HFrEF and HFpEF groups. The most common precipitants were arrhythmia (15%), other non-CV factors (11%) and respiratory infection (10%). Subsequent CV readmission rates were highest in those whose initial HF hospitalization was precipitated by CV factors. However, mortality rates were similar among patients with any of the three categories of precipitating factors. Results were similar in HFrEF and HFpEF.\ud Conclusions:\ud \ud Among chronic HF patients hospitalized for decompensation, the investigator-reported precipitating factor was not associated with the subsequent mortality rate, but was associated with type of readmission: readmissions for CV reasons were more likely when the index precipitant was CV.

Published
2018

31. Association of diabetes and kidney function according to age and systolic function with the incidence of sudden cardiac death and non‐sudden cardiac death in myocardial infarction survivors with heart failure

Author

Coiro, Stefano, primary, Girerd, Nicolas, additional, Sharma, Abhinav, additional, Rossignol, Patrick, additional, Tritto, Isabella, additional, Pitt, Bertram, additional, Pfeffer, Marc A., additional, McMurray, John J.V., additional, Ambrosio, Giuseppe, additional, Dickstein, Kenneth, additional, Moss, Arthur, additional, and Zannad, Faiez, additional

Published
2019
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32. Metformin use and cardiovascular events in patients with type 2 diabetes and chronic kidney disease

Author

Charytan, David M., primary, Solomon, Scott D., additional, Ivanovich, Peter, additional, Remuzzi, Giuseppe, additional, Cooper, Mark E., additional, McGill, Janet B., additional, Parving, Hans‐Henrik, additional, Parfrey, Patrick, additional, Singh, Ajay K., additional, Burdmann, Emmanuel A., additional, Levey, Andrew S., additional, Eckardt, Kai‐Uwe, additional, McMurray, John J.V., additional, Weinrauch, Larry A., additional, Liu, Jiankang, additional, Claggett, Brian, additional, Lewis, Eldrin F., additional, and Pfeffer, Marc A., additional

Published
2019
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34. The frailty syndrome and outcomes in the TOPCAT trial

Author

Sanders, Natalie A., primary, Supiano, Mark A., additional, Lewis, Eldrin F., additional, Liu, Jiankang, additional, Claggett, Brian, additional, Pfeffer, Marc A., additional, Desai, Akshay S., additional, Sweitzer, Nancy K., additional, Solomon, Scott D., additional, and Fang, James C., additional

Published
2018
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36. Systolic blood pressure and cardiovascular outcomes in heart failure with preserved ejection fraction: an analysis of the TOPCAT trial

Author

Selvaraj, Senthil, primary, Claggett, Brian, additional, Shah, Sanjiv J., additional, Anand, Inder, additional, Rouleau, Jean L., additional, Desai, Akshay S., additional, Lewis, Eldrin F., additional, Pitt, Bertram, additional, Sweitzer, Nancy K., additional, Pfeffer, Marc A., additional, and Solomon, Scott D., additional

Published
2017
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37. Influence of ejection fraction on cause‐specific mortality in heart failure with preserved ejection fraction

Author

Bajaj, Navkaranbir S., primary, Claggett, Brian, additional, Lewis, Eldrin F., additional, Desai, Akshay S., additional, Fang, James C., additional, O'Meara, Eileen, additional, Shah, Sanjiv J., additional, Sweitzer, Nancy K., additional, Fleg, Jerome L., additional, Pitt, Bertram, additional, Rouleau, Jean L., additional, Finn, Peter, additional, Pfeffer, Marc A., additional, and Solomon, Scott D., additional

Published
2017
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38. Prognostic importance of emerging cardiac, inflammatory, and renal biomarkers in chronic heart failure patients with reduced ejection fraction and anaemia: RED-HF study

Author

Welsh, Paul, primary, Kou, Lei, additional, Yu, Changhong, additional, Anand, Inder, additional, van Veldhuisen, Dirk J., additional, Maggioni, Aldo P., additional, Desai, Akshay S., additional, Solomon, Scott D., additional, Pfeffer, Marc A., additional, Cheng, Sunfa, additional, Gullestad, Lars, additional, Aukrust, Pål, additional, Ueland, Thor, additional, Swedberg, Karl, additional, Young, James B., additional, Kattan, Michael W., additional, Sattar, Naveed, additional, and McMurray, John J.V., additional

Published
2017
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40. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment

Author

Cowie, Martin R., primary, Filippatos, Gerasimos S., additional, Alonso Garcia, Maria de los Angeles, additional, Anker, Stefan D., additional, Baczynska, Anna, additional, Bloomfield, Daniel M., additional, Borentain, Maria, additional, Bruins Slot, Karsten, additional, Cronin, Maureen, additional, Doevendans, Pieter A., additional, El-Gazayerly, Amany, additional, Gimpelewicz, Claudio, additional, Honarpour, Narimon, additional, Janmohamed, Salim, additional, Janssen, Heidi, additional, Kim, Albert M., additional, Lautsch, Dominik, additional, Laws, Ian, additional, Lefkowitz, Martin, additional, Lopez-Sendon, Jose, additional, Lyon, Alexander R., additional, Malik, Fady I., additional, McMurray, John J.V., additional, Metra, Marco, additional, Figueroa Perez, Santiago, additional, Pfeffer, Marc A., additional, Pocock, Stuart J., additional, Ponikowski, Piotr, additional, Prasad, Krishna, additional, Richard-Lordereau, Isabelle, additional, Roessig, Lothar, additional, Rosano, Giuseppe M.C., additional, Sherman, Warren, additional, Stough, Wendy Gattis, additional, Swedberg, Karl, additional, Tyl, Benoit, additional, Zannad, Faiez, additional, Boulton, Caroline, additional, and De Graeff, Pieter, additional

Published
2017
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42. Severity of renal impairment in patients with heart failure and atrial fibrillation: implications for non-vitamin K antagonist oral anticoagulant dose adjustment

Author

Hawkins, Nathaniel M., primary, Jhund, Pardeep S., additional, Pozzi, Andrea, additional, O'Meara, Eileen, additional, Solomon, Scott D., additional, Granger, Christopher B., additional, Yusuf, Salim, additional, Pfeffer, Marc A., additional, Swedberg, Karl, additional, Petrie, Mark C., additional, Virani, Sean, additional, and McMurray, John J.V., additional

Published
2016
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43. Worsening renal function and outcome in heart failure patients with reduced and preserved ejection fraction and the impact of angiotensin receptor blocker treatment: data from the CHARM-study programme

Author

Damman, Kevin, primary, Solomon, Scott D., additional, Pfeffer, Marc A., additional, Swedberg, Karl, additional, Yusuf, Salim, additional, Young, James B., additional, Rouleau, Jean L., additional, Granger, Christopher B., additional, and McMurray, John J.V., additional

Published
2016
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44. Increased risk of stroke with darbepoetin alfa in anaemic heart failure patients with diabetes and chronic kidney disease

Author

Bello, Natalie A., primary, Lewis, Eldrin F., additional, Desai, Akshay S., additional, Anand, Inder S., additional, Krum, Henry, additional, McMurray, John J.V., additional, Olson, Kurt, additional, Solomon, Scott D., additional, Swedberg, Karl, additional, van Veldhuisen, Dirk J., additional, Young, James B., additional, and Pfeffer, Marc A., additional

Published
2015
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46. Sex differences in clinical characteristics and outcomes after myocardial infarction: insights from the Valsartan in Acute Myocardial Infarction Trial (VALIANT)

Author

Lam, Carolyn S. P., primary, McEntegart, Margaret, additional, Claggett, Brian, additional, Liu, Jiankang, additional, Skali, Hicham, additional, Lewis, Eldrin, additional, Køber, Lars, additional, Rouleau, Jean, additional, Velazquez, Eric, additional, Califf, Rob, additional, McMurray, John J., additional, Pfeffer, Marc, additional, and Solomon, Scott, additional

Published
2015
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47. Clinical characteristics and outcomes of patients with angina and heart failure in the CHARM (Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity) Programme

Author

Badar, Athar A., primary, Perez-Moreno, Ana C., additional, Hawkins, Nathaniel M., additional, Brunton, Alan P.T., additional, Jhund, Pardeep S., additional, Wong, Chih M., additional, Solomon, Scott D., additional, Granger, Christopher B., additional, Yusuf, Salim, additional, Pfeffer, Marc A., additional, Swedberg, Karl, additional, Gardner, Roy S., additional, Petrie, Mark C., additional, and McMurray, John J.V., additional

Published
2015
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48. Corrigendum to ‘Analysing recurrent hospitalizations in heart failure: a review of statistical methodology, with application to CHARM-Preserved’ [Eur J Heart Fail2014;16:33-40]

Author

Rogers, Jennifer K., primary, Pocock, Stuart J., additional, McMurray, John J.V., additional, Granger, Christopher B., additional, Michelson, Eric L., additional, Östergren, Jan, additional, Pfeffer, Marc A., additional, Solomon, Scott D., additional, Swedberg, Karl, additional, and Yusuf, Salim, additional

Published
2014
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49. Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT

Author

Skali, Hicham, primary, Dwyer, Edward M., additional, Goldstein, Robert, additional, Haigney, Mark, additional, Krone, Ronald, additional, Kukin, Marrick, additional, Lichstein, Edgar, additional, McNitt, Scott, additional, Moss, Arthur J., additional, Pfeffer, Marc A., additional, and Solomon, Scott D., additional

Published
2014
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