Design and rationale of studies of neurohormonal blockade and outcomes in diastolic heart failure using OPTIMIZE-HF registry linked to Medicare data

Abstract

BackgroundHeart 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. MethodsThe 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. ResultsUsing 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 75years, mean EF of 55%, were 62% women, 15% African American, and were comparable with community-based HF–PEF cohorts in key baseline characteristics. ConclusionsThe 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.