Treating anemia in older adults with heart failure with a preserved ejection fraction with epoetin alfa: single-blind randomized clinical trial of safety and efficacy

Circ Heart Fail. 2013 Mar;6(2):254-63. doi: 10.1161/CIRCHEARTFAILURE.112.969717. Epub 2012 Dec 20.

Abstract

Background: Anemia is a common comorbidity in older adults with heart failure and a preserved ejection fraction and is associated with worse outcomes. We hypothesized that treating anemia with subcutaneous epoetin alfa would be associated with reverse ventricular remodeling and improved exercise capacity and health status compared with placebo.

Methods and results: Prospective, randomized, single-blind, 24-week study with blinded end point assessment among anemic (average hemoglobin of 10.4±1 g/dL) older adult patients (n=56; 77±11 years; 68% women) with heart failure and a preserved ejection fraction (ejection fraction=63±15%; B-type natriuretic peptide=431±366 pg/mL) was conducted. Treatment with epoetin alfa resulted in significant increases in hemoglobin (P<0.0001). Changes in end-diastolic volume (-6±14 versus -4±16 mL; P=0.67) at 6 months did not differ between epoetin alfa and placebo, but declines in stroke volume (-5±8 versus 2±10 mL; P=0.09) without significant changes in left ventricular mass were observed. Changes in 6-minute walk distance (16±11 versus 5±12 m; P=0.52) did not differ. Although quality of life improved by the Kansas City Cardiomyopathy Questionnaire and the Minnesota Living with Heart Failure Questionnaire in both cohorts, there were no significant differences between groups.

Conclusions: Administration of epoetin alfa to older adult patients with heart failure and a preserved ejection fraction compared with placebo did not change left ventricular end-diastolic volume and left ventricular mass nor did it improve submaximal exercise capacity or quality of life.

Clinical trial registration: URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00286182.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Age Factors
  • Aged
  • Aged, 80 and over
  • Anemia / blood
  • Anemia / drug therapy*
  • Anemia / epidemiology
  • Anemia / physiopathology
  • Biomarkers / blood
  • Chi-Square Distribution
  • Comorbidity
  • Epoetin Alfa
  • Erythropoietin / therapeutic use*
  • Exercise Test
  • Exercise Tolerance / drug effects
  • Female
  • Heart Failure / blood
  • Heart Failure / epidemiology
  • Heart Failure / physiopathology*
  • Hematinics / therapeutic use*
  • Hemoglobins / metabolism
  • Humans
  • Male
  • Middle Aged
  • Natriuretic Peptide, Brain / blood
  • New York City / epidemiology
  • Prospective Studies
  • Quality of Life
  • Recombinant Proteins / therapeutic use
  • Recovery of Function
  • Single-Blind Method
  • Stroke Volume / drug effects*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Ventricular Remodeling / drug effects
  • Walking

Substances

  • Biomarkers
  • Hematinics
  • Hemoglobins
  • Recombinant Proteins
  • Erythropoietin
  • Natriuretic Peptide, Brain
  • Epoetin Alfa

Associated data

  • ClinicalTrials.gov/NCT00286182