title: 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.
  
  
  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.affiliation: Duke Clinical Research Institute.
authors.forename: Teresa S
authors.initials: TS
authors.lastname: Wang
authors.forename: Anne S
authors.initials: AS
authors.lastname: Hellkamp
authors.forename: Chetan B
authors.initials: CB
authors.lastname: Patel
authors.forename: Justin A
authors.initials: JA
authors.lastname: Ezekowitz
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Hernandez
mesh_terms: D000208:Acute Disease; D001210:Asia, Southeastern; D001315:Australia; D006333:Heart Failure / Q000188:drug therapy* / Q000453:epidemiology* / Q000401:mortality; D006801:Humans; D007391:International Cooperation; D007843:Latin America; D018579:Patient Selection; D044382:Population Groups / Q000706:statistics & numerical data*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012042:Registries / Q000706:statistics & numerical data*; D012065:Relaxin / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome; D014481:United States
chemical_list: D011994:Recombinant Proteins; C577649:serelaxin protein, human; D012065:Relaxin
keywords: relaxin