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: Yan Zhang, Meredith L Kilgore, Tarun Arora, Marjan Mujib, O James Ekundayo, Inmaculada B Aban, Margaret A Feller, Ravi V Desai, Thomas E Love, Richard M Allman, Gregg C Fonarow, Ali Ahmed
• Journal: International journal of cardiology (Int J Cardiol) Vol. 166 Issue 1 Pg. 230-5 (Jun 05 2013) ISSN: 1874-1754 [Electronic] Netherlands
• PMID: 22119116 (Publication Type: Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Published by Elsevier Ireland Ltd.

Chemical References

• Hormone Antagonists
• Neurotransmitter Agents

Topics

• Aged
• Aged, 80 and over
• Cohort Studies
• Databases, Factual
• Female
• Heart Failure, Diastolic (blood, drug therapy, epidemiology)
• Hormone Antagonists (therapeutic use)
• Humans
• Male
• Medicare
• Middle Aged
• Neural Inhibition (physiology)
• Neurotransmitter Agents (antagonists & inhibitors, blood)
• Registries
• Treatment Outcome
• United States (epidemiology)