title: A Critical Evaluation of the Representation of Black Patients With Heart Failure and Preserved Ejection Fraction in Clinical Trials: A Literature Review.
abstract: BACKGROUND
  In the United States, heart failure costs $34.4 billion annually and is associated with a mortality rate of 20% within 5 years of diagnosis. Heart failure preserved ejection fraction (HFpEF) accounts for 50% of all hospital admissions for heart failure. Black patients develop HFpEF at a significantly earlier age than do white patients, and the 5-year mortality rate for blacks with HFpEF is 30% to 44% higher compared with white patients. Current trials may not represent black patients proportionately to the general population.
  
  
  OBJECTIVE
  The primary aim of this literature review was to critically evaluate the representation of black patients in HFpEF trials and propose solutions for future research.
  
  
  METHODS
  PubMed and CINAHL were queried for peer-reviewed journal articles from 1997 to 2014 using 2 sets of search terms that included HFpEF or preserved left ventricular function and all relevant search terms for black patients. Initially, 182 articles were identified; however, after exclusionary criteria were applied, 22 articles remained. After critical review of each article for relevance, a total of 9 articles remained for the review.
  
  
  RESULTS
  For the 9 trials reviewed including a total of 63,065 patients with HFpEF, 10,436 (17%) of the patients were black. Three of the 9 trials included less than 10% black patients, 4 trials included 10% to 20% black patients, and 2 trials included greater than 20% black patients. In 2 studies, the percentage of black patients in the HFpEF trial (13% and 17%) was significantly less than the percentage of black patients in the general regional population (53% and 39%), respectively.
  
  
  CONCLUSIONS
  Although the mortality rate for black patients with HFpEF is 30% to 45% higher than the rate for white patients, 2 of the 9 studies did not have a representative sample of the general HFpEF population and none of the studies reported the objective of establishing a representative study population.
authors: Carolyn L. Lekavich, MSN, MHS-CL, ANP-C PhD Candidate, School of Nursing, University of North Carolina at Chapel Hill.Debra J. Barksdale, PhD, FNP-BC, FAANP, FAAN Professor, School of Nursing, University of North Carolina at Chapel Hill.
authors: Carolyn L
authors: CL
authors: Lekavich
authors: Debra J
authors: DJ
authors: Barksdale
mesh_terms: D001741:Black or African American; D002986:Clinical Trials as Topic; D006333:Heart Failure / Q000208:ethnology* / Q000503:physiopathology; D006801:Humans; D018579:Patient Selection; D013318:Stroke Volume