Representativeness of RELAX-AHF clinical trial population in acute heart failure.

Abstract

BACKGROUND:

The Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF) trial enrolled 1161 patients admitted to the hospital for acute heart failure (AHF) to evaluate the therapeutic efficacy of serelaxin, a recombinant form of human relaxin-2. We characterized how representative RELAX-AHF clinical trial enrollees were to those patients with AHF found in international registries.

METHODS AND RESULTS:

We examined 196 770 AHF admissions from the Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries. Patients were considered RELAX-AHF-type if they met the following criteria: discharge diagnosis of heart failure, systolic blood pressure >125 mm Hg, dyspnea at rest or with mild exertion, intravenous diuretic use, glomerular filtration rate of 30 to 75 mL/min per 1.73 m(2), hemoglobin >8 g/dL, and no use of intravenous inotropes or vasopressors. Baseline characteristics and treatments of RELAX-AHF-type and non-RELAX-AHF-type patients were compared. A Cox model was used to evaluate inpatient mortality. Among both Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries, 20.7% (n=38 485) and 16.2% (n=1749) of patients met basic criteria for RELAX-AHF entry, respectively. These patients were more likely to be older, be women, have a previous history of hypertension, have preserved ejection fraction, and have better renal function. In-hospital mortality was lower in RELAX-AHF-type than in non-RELAX-AHF-type patients, even after multivariable adjustment (hazard ratio, 0.59; 95% confidence interval, 0.53-0.66; P<0.0001).

CONCLUSIONS:

Patients potentially eligible for RELAX-AHF represent ≈2 in 10 patients with AHF in the United States, Latin America, or Asia-Pacific. These patients differ significantly from other hospitalized patients based on clinical characteristics and outcomes.

• Authors: Teresa S Wang, Anne S Hellkamp, Chetan B Patel, Justin A Ezekowitz, Gregg C Fonarow, Adrian F Hernandez
• Journal: Circulation. Cardiovascular quality and outcomes (Circ Cardiovasc Qual Outcomes) Vol. 7 Issue 2 Pg. 259-68 (Mar 2014) ISSN: 1941-7705 [Electronic] United States
• PMID: 24594552 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• serelaxin protein, human
• Relaxin

Topics

• Acute Disease
• Asia, Southeastern
• Australia
• Heart Failure (drug therapy, epidemiology, mortality)
• Humans
• International Cooperation
• Latin America
• Patient Selection
• Population Groups (statistics & numerical data)
• Recombinant Proteins (administration & dosage, adverse effects)
• Registries (statistics & numerical data)
• Relaxin (administration & dosage, adverse effects)
• Survival Analysis
• Treatment Outcome
• United States