Evaluating the Efficacy, Safety, and Tolerability of Serelaxin When Added to Standard Therapy in Asian Patients With Acute Heart Failure: Design and Rationale of RELAX-AHF-ASIA Trial

Naoki Sato, Carolyn S.P. Lam, John R. Teerlink, Barry H. Greenberg, Hiroyuki Tsutsui, Byung Hee Oh, Jian Zhang, Martin Lefkowitz, Tsushung A. Hua, Thomas Holbro, Miriam Marshood, Xing Li Wang, Junbo Ge

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background Acute heart failure (AHF), a common and growing health concern worldwide, is associated with high risk of post-discharge rehospitalization and mortality. Existing evidence indicates potential therapeutic benefits of serelaxin in Caucasian AHF patients, but corresponding data in Asians remain scarce. RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments. Methods and Results Patients with AHF, systolic blood pressure ≥125 mm Hg, and mild to moderate renal dysfunction will be randomized within 16 hours of presentation to receive 48-hour intravenous infusion of 30 µg ⋅ kg−1 ⋅ d−1 serelaxin or placebo in addition to standard therapy. The composite primary end point includes: (1) treatment success (moderate/marked improvement in patient-reported dyspnea and physician-assessed signs of congestion on day 2); (2) treatment failure (in-hospital worsening of signs and/or symptoms of heart failure [HF] requiring intensification of intravenous HF therapy or mechanical ventilation, renal/circulatory support, rehospitalization due to HF/renal-failure, or death through day 5); and (3) unchanged status. Secondary end points include time to in-hospital worsening HF through day 5 and all-cause and cardiovascular deaths through day 180. Conclusions RELAX-AHF-ASIA, the largest randomized clinical trial in Asian AHF patients to date, has a novel composite primary end point and the potential to become a hallmark of AHF trials.

Original languageEnglish
Pages (from-to)63-71
Number of pages9
JournalJournal of Cardiac Failure
Volume23
Issue number1
DOIs
Publication statusPublished - Jan 1 2017

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Heart Failure
Safety
Therapeutics
Placebos
Blood Pressure
Kidney
Treatment Failure
Artificial Respiration
Intravenous Infusions
Dyspnea
Signs and Symptoms
Renal Insufficiency
Cause of Death
Randomized Controlled Trials
Physicians
Mortality

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Evaluating the Efficacy, Safety, and Tolerability of Serelaxin When Added to Standard Therapy in Asian Patients With Acute Heart Failure : Design and Rationale of RELAX-AHF-ASIA Trial. / Sato, Naoki; Lam, Carolyn S.P.; Teerlink, John R.; Greenberg, Barry H.; Tsutsui, Hiroyuki; Oh, Byung Hee; Zhang, Jian; Lefkowitz, Martin; Hua, Tsushung A.; Holbro, Thomas; Marshood, Miriam; Wang, Xing Li; Ge, Junbo.

In: Journal of Cardiac Failure, Vol. 23, No. 1, 01.01.2017, p. 63-71.

Research output: Contribution to journalArticle

Sato, Naoki ; Lam, Carolyn S.P. ; Teerlink, John R. ; Greenberg, Barry H. ; Tsutsui, Hiroyuki ; Oh, Byung Hee ; Zhang, Jian ; Lefkowitz, Martin ; Hua, Tsushung A. ; Holbro, Thomas ; Marshood, Miriam ; Wang, Xing Li ; Ge, Junbo. / Evaluating the Efficacy, Safety, and Tolerability of Serelaxin When Added to Standard Therapy in Asian Patients With Acute Heart Failure : Design and Rationale of RELAX-AHF-ASIA Trial. In: Journal of Cardiac Failure. 2017 ; Vol. 23, No. 1. pp. 63-71.
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abstract = "Background Acute heart failure (AHF), a common and growing health concern worldwide, is associated with high risk of post-discharge rehospitalization and mortality. Existing evidence indicates potential therapeutic benefits of serelaxin in Caucasian AHF patients, but corresponding data in Asians remain scarce. RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments. Methods and Results Patients with AHF, systolic blood pressure ≥125 mm Hg, and mild to moderate renal dysfunction will be randomized within 16 hours of presentation to receive 48-hour intravenous infusion of 30 µg ⋅ kg−1 ⋅ d−1 serelaxin or placebo in addition to standard therapy. The composite primary end point includes: (1) treatment success (moderate/marked improvement in patient-reported dyspnea and physician-assessed signs of congestion on day 2); (2) treatment failure (in-hospital worsening of signs and/or symptoms of heart failure [HF] requiring intensification of intravenous HF therapy or mechanical ventilation, renal/circulatory support, rehospitalization due to HF/renal-failure, or death through day 5); and (3) unchanged status. Secondary end points include time to in-hospital worsening HF through day 5 and all-cause and cardiovascular deaths through day 180. Conclusions RELAX-AHF-ASIA, the largest randomized clinical trial in Asian AHF patients to date, has a novel composite primary end point and the potential to become a hallmark of AHF trials.",
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T1 - Evaluating the Efficacy, Safety, and Tolerability of Serelaxin When Added to Standard Therapy in Asian Patients With Acute Heart Failure

T2 - Design and Rationale of RELAX-AHF-ASIA Trial

AU - Sato, Naoki

AU - Lam, Carolyn S.P.

AU - Teerlink, John R.

AU - Greenberg, Barry H.

AU - Tsutsui, Hiroyuki

AU - Oh, Byung Hee

AU - Zhang, Jian

AU - Lefkowitz, Martin

AU - Hua, Tsushung A.

AU - Holbro, Thomas

AU - Marshood, Miriam

AU - Wang, Xing Li

AU - Ge, Junbo

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Background Acute heart failure (AHF), a common and growing health concern worldwide, is associated with high risk of post-discharge rehospitalization and mortality. Existing evidence indicates potential therapeutic benefits of serelaxin in Caucasian AHF patients, but corresponding data in Asians remain scarce. RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments. Methods and Results Patients with AHF, systolic blood pressure ≥125 mm Hg, and mild to moderate renal dysfunction will be randomized within 16 hours of presentation to receive 48-hour intravenous infusion of 30 µg ⋅ kg−1 ⋅ d−1 serelaxin or placebo in addition to standard therapy. The composite primary end point includes: (1) treatment success (moderate/marked improvement in patient-reported dyspnea and physician-assessed signs of congestion on day 2); (2) treatment failure (in-hospital worsening of signs and/or symptoms of heart failure [HF] requiring intensification of intravenous HF therapy or mechanical ventilation, renal/circulatory support, rehospitalization due to HF/renal-failure, or death through day 5); and (3) unchanged status. Secondary end points include time to in-hospital worsening HF through day 5 and all-cause and cardiovascular deaths through day 180. Conclusions RELAX-AHF-ASIA, the largest randomized clinical trial in Asian AHF patients to date, has a novel composite primary end point and the potential to become a hallmark of AHF trials.

AB - Background Acute heart failure (AHF), a common and growing health concern worldwide, is associated with high risk of post-discharge rehospitalization and mortality. Existing evidence indicates potential therapeutic benefits of serelaxin in Caucasian AHF patients, but corresponding data in Asians remain scarce. RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments. Methods and Results Patients with AHF, systolic blood pressure ≥125 mm Hg, and mild to moderate renal dysfunction will be randomized within 16 hours of presentation to receive 48-hour intravenous infusion of 30 µg ⋅ kg−1 ⋅ d−1 serelaxin or placebo in addition to standard therapy. The composite primary end point includes: (1) treatment success (moderate/marked improvement in patient-reported dyspnea and physician-assessed signs of congestion on day 2); (2) treatment failure (in-hospital worsening of signs and/or symptoms of heart failure [HF] requiring intensification of intravenous HF therapy or mechanical ventilation, renal/circulatory support, rehospitalization due to HF/renal-failure, or death through day 5); and (3) unchanged status. Secondary end points include time to in-hospital worsening HF through day 5 and all-cause and cardiovascular deaths through day 180. Conclusions RELAX-AHF-ASIA, the largest randomized clinical trial in Asian AHF patients to date, has a novel composite primary end point and the potential to become a hallmark of AHF trials.

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