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1. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX‐AHF‐2 study

Author

Teerlink, John R, Voors, Adriaan A, Ponikowski, Piotr, Pang, Peter S, Greenberg, Barry H, Filippatos, Gerasimos, Felker, G Michael, Davison, Beth A, Cotter, Gad, Gimpelewicz, Claudio, Boer‐Martins, Leandro, Wernsing, Margaret, Hua, Tsushung A, Severin, Thomas, and Metra, Marco

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Patient Safety, Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Aging, Heart Disease, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Acute Disease, Aged, Cause of Death, Dose-Response Relationship, Drug, Double-Blind Method, Europe, Female, Follow-Up Studies, Heart Failure, Humans, Incidence, Infusions, Intravenous, Male, Recombinant Proteins, Relaxin, Renal Insufficiency, Survival Rate, Time Factors, Treatment Outcome, United States, Acute heart failure, Serelaxin, Worsening heart failure, Mortality, Phase 3 trial, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Patients admitted for acute heart failure (AHF) experience high rates of in-hospital and post-discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin-2, a hormone with vasodilatory and end-organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX-AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all-cause and cardiovascular mortality by 37% through day 180. RELAX-AHF-2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX-AHF-2 is a multicentre, randomized, double-blind, placebo-controlled, event-driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild-to-moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all-cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in-hospital length of stay during index AHF. The results from RELAX-AHF-2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.

Published
2017

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

Abstract

Aims: Patients surviving an acute myocardial infarction (AMI) are at risk of developing symptomatic heart failure (HF) or premature death. We hypothesized that sacubitril/valsartan, effective in the treatment of chronic HF, prevents development of HF and reduces cardiovascular death following high-risk AMI compared to a proven angiotensin-converting enzyme (ACE) inhibitor. This paper describes the study design and baseline characteristics of patients enrolled in the Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction (PARADISE-MI) trial. Methods and results: PARADISE-MI, a multinational (41 countries), double-blind, active-controlled trial, randomized patients within 0.5–7 days of presentation with index AMI to sacubitril/valsartan or ramipril. Transient pulmonary congestion and/or left ventricular ejection fraction (LVEF) ≤40% and at least one additional factor augmenting risk of HF or death (age ≥70 years, estimated glomerular filtration rate <60 mL/min/1.73 m2, diabetes, prior myocardial infarction, atrial fibrillation, LVEF <30%, Killip class ≥III, ST-elevation myocardial infarction without reperfusion) were required for inclusion. PARADISE-MI was event-driven targeting 708 primary endpoints (cardiovascular death, HF hospitalization or outpatient development of HF). Randomization of 5669 patients occurred 4.3 ± 1.8 days from presentation with index AMI. The mean age was 64 ± 12 years, 24% were women. The majority (76%) qualified with ST-segment elevation myocardial infarction; acute percutaneous coronary intervention was performed in 88% and thrombolysis in 6%. LVEF was 37 ± 9% and 58% were in Killip class ≥II. Conclusions: Baseline therapies in PARADISE-MI reflect advances in contemporary evidence-based care. With enrollment complete PARADISE-MI is poised to determine whether sacubitril/valsartan is more effective than a proven ACE inhibitor in preventing development

Published
2021

4. 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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7. Serelaxin in addition to standard therapy in acute heart failure: Rationale and design of the RELAX-AHF-2 study

Author

Teerlink, John R., Voors, Adriaan A., Ponikowski, Piotr, Pang, Peter S., Greenberg, Barry H., Filippatos, Gerasimos, Felker, G. Michael, Davison, Beth A., Cotter, Gad, Gimpelewicz, Claudio, Boer-Martins, Leandro, Wernsing, Margaret, Hua, Tsushung A., Severin, Thomas, Metra, Marco, and Cardiovascular Centre (CVC)

Subjects
Male, Infusions, Time Factors, IMPACT, Trial Design, Worsening heart failure, Cardiorespiratory Medicine and Haematology, Phase 3 trial, GUIDELINES, Dose-Response Relationship, Double-Blind Method, Cause of Death, Humans, Renal Insufficiency, Mortality, Infusions, Intravenous, Aged, Heart Failure, OUTCOMES, Dose-Response Relationship, Drug, Serelaxin, Incidence, Relaxin, Acute heart failure, ASSOCIATION, Recombinant Proteins, United States, Europe, Survival Rate, Treatment Outcome, Cardiovascular System & Hematology, PRESERVED EJECTION FRACTION, HOSPITALIZATION, Acute Disease, Female, TRIAL, Drug, RELAX-AHF, Cardiology and Cardiovascular Medicine, Intravenous, SUBSEQUENT MORTALITY, Follow-Up Studies, TASK-FORCE
Abstract

Patients admitted for acute heart failure (AHF) experience high rates of in‐hospital and post‐discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin‐2, a hormone with vasodilatory and end‐organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX‐AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all‐cause and cardiovascular mortality by 37% through day 180. RELAX‐AHF‐2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX‐AHF‐2 is a multicentre, randomized, double‐blind, placebo‐controlled, event‐driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild‐to‐moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all‐cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in‐hospital length of stay during index AHF. The results from RELAX‐AHF‐2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.

Published
2017

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