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Design of the RELAXin in acute heart failure study.

Abstract：

BACKGROUND:Acute heart failure (AHF) remains a major public health burden with a high prevalence and poor prognosis. Relaxin is a naturally occurring peptide hormone that increases cardiac output, arterial compliance, and renal blood flow during pregnancy. The RELAX-AHF-1 study will evaluate the effect of RLX030 (recombinant form of human relaxin 2) on symptom relief and clinical outcomes in patients with AHF. METHODS:The protocol includes a completed phase 2 234-patient dose-finding study (Pre-RELAX-AHF) and an ongoing phase 3 1,160-patient trial (RELAX-AHF-1). Patients with AHF and systolic blood pressure >125 mm Hg are randomized within 16 hours of presentation to a 48-hour IV infusion of RLX030 or placebo. The 30 μg/kg per day dose of RLX030 was chosen for RELAX-AHF-1 based on effects on dyspnea, clinical outcomes, and safety observed in Pre-RELAX-AHF. Primary efficacy end points in RELAX-AHF-1 are (1) the area under the curve of change of the dyspnea Visual Analog Scale from baseline through day 5 and (2) whether the patient reports moderately to markedly better dyspnea at 6, 12, and 24 hours. Secondary efficacy end points include days alive and out of the hospital through day 60 and cardiovascular death or rehospitalization for heart failure or renal failure through day 60. Patients will be followed up through day 180 for mortality. As of September 19, 2011, 978 patients have been enrolled. CONCLUSIONS:Pre-RELAX-AHF results suggested that infusion of RLX030 may accelerate dyspnea relief and improve prognosis in patients hospitalized with AHF. RELAX-AHF-1 will further evaluate these effects.

journal_name

Am Heart J

journal_title

American heart journal

authors

Ponikowski P,Metra M,Teerlink JR,Unemori E,Felker GM,Voors AA,Filippatos G,Greenberg B,Teichman SL,Severin T,Mueller-Velten G,Cotter G,Davison BA

doi

10.1016/j.ahj.2011.10.009

subject

Has Abstract

pub_date

2012-02-01 00:00:00

pages

149-55.e1

issue

2

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(11)00724-1

journal_volume

163

pub_type

杂志文章,多中心研究,随机对照试验

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