title: 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.
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.
  
  
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00286182.
authors.affiliation: Columbia University Medical Center, New York, NY, USA. msm10@columbia.edu
authors.forename: Mathew S
authors.initials: MS
authors.lastname: Maurer
authors.forename: Sergio
authors.initials: S
authors.lastname: Teruya
authors.forename: Bibhas
authors.initials: B
authors.lastname: Chakraborty
authors.forename: Stephen
authors.initials: S
authors.lastname: Helmke
authors.forename: Donna
authors.initials: D
authors.lastname: Mancini
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D015415:Biomarkers / Q000097:blood; D016009:Chi-Square Distribution; D015897:Comorbidity; D000068817:Epoetin Alfa; D004921:Erythropoietin / Q000627:therapeutic use*; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D006333:Heart Failure / Q000097:blood / Q000453:epidemiology / Q000503:physiopathology*; D006397:Hematinics / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D009519:New York City / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D020127:Recovery of Function; D016037:Single-Blind Method; D013318:Stroke Volume / Q000187:drug effects*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D020257:Ventricular Remodeling / Q000187:drug effects; D016138:Walking
chemical_list: D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D020097:Natriuretic Peptide, Brain; D000068817:Epoetin Alfa