title: Design and rationale of studies of neurohormonal blockade and outcomes in diastolic heart failure using OPTIMIZE-HF registry linked to Medicare data.
abstract: BACKGROUND
  Heart failure (HF) is the leading cause of hospitalization for Medicare beneficiaries. Nearly half of all HF patients have diastolic HF or HF with preserved ejection fraction (HF-PEF). Because these patients were excluded from major randomized clinical trials of neurohormonal blockade in HF there is little evidence about their role in HF-PEF.
  
  
  METHODS
  The aims of the American Recovery & Reinvestment Act-funded National Heart, Lung, and Blood Institute-sponsored "Neurohormonal Blockade and Outcomes in Diastolic Heart Failure" are to study the long-term effects of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and aldosterone antagonists in four separate propensity-matched populations of HF-PEF patients in the OPTIMIZE-HF (Organized Program to Initiate Life-Saving Treatment in Hospitalized Patients with Heart Failure) registry. Of the 48,612 OPTIMIZE-HF hospitalizations occurring during 2003-2004 in 259 U.S. hospitals, 20,839 were due to HF-PEF (EF ≥40%). For mortality and hospitalization we used Medicare national claims data through December 31, 2008.
  
  
  RESULTS
  Using a two-step (hospital-level and hospitalization-level) probabilistic linking approach, we assembled a cohort of 11,997 HF-PEF patients from 238 OPTIMIZE-HF hospitals. These patients had a mean age of 75 years, mean EF of 55%, were 62% women, 15% African American, and were comparable with community-based HF-PEF cohorts in key baseline characteristics.
  
  
  CONCLUSIONS
  The assembled Medicare-linked OPTIMIZE-HF cohort of Medicare beneficiaries with HF-PEF with long-term outcomes data will provide unique opportunities to study clinical effectivenss of various neurohormonal antagonists with outcomes in HF-PEF using propensity-matched designs that allow outcome-blinded assembly of balanced cohorts, a key feature of randomized clinical trials.
authors: University of Alabama at Birmingham, Birmingham, AL 35294–2041, USA.
authors: Yan
authors: Y
authors: Zhang
authors: Meredith L
authors: ML
authors: Kilgore
authors: Tarun
authors: T
authors: Arora
authors: Marjan
authors: M
authors: Mujib
authors: O James
authors: OJ
authors: Ekundayo
authors: Inmaculada B
authors: IB
authors: Aban
authors: Margaret A
authors: MA
authors: Feller
authors: Ravi V
authors: RV
authors: Desai
authors: Thomas E
authors: TE
authors: Love
authors: Richard M
authors: RM
authors: Allman
authors: Gregg C
authors: GC
authors: Fonarow
authors: Ali
authors: A
authors: Ahmed
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D016208:Databases, Factual; D005260:Female; D054144:Heart Failure, Diastolic / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D006727:Hormone Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D006278:Medicare; D008875:Middle Aged; D009433:Neural Inhibition / Q000502:physiology*; D018377:Neurotransmitter Agents / Q000037:antagonists & inhibitors / Q000097:blood; D012042:Registries; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D006727:Hormone Antagonists; D018377:Neurotransmitter Agents