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The challenges associated with current clinical trials for diastolic heart failure

Vinay Thohan1, Shomeet Patel

  • 1Department of Cardiology, Wake Forest University School of Medicine, Medical Center Boulevard, Watlington One, Winston-Salem 27157, North Carolina, USA. vthohan@wfubmc.edu

Current Opinion in Cardiology
|March 26, 2009
PubMed

Insights

Diastolic heart failure (DHF) trials have not shown significant benefits. Improving clinical trial design by enrolling high-risk patients with specific criteria is crucial for future DHF research.

Area of Science:

  • Cardiology
  • Heart Failure Research
  • Clinical Trials

Background:

  • Diastolic heart failure (DHF) affects over half of elderly heart failure patients, mirroring systolic heart failure (SHF) in morbidity and mortality.
  • Increasing prevalence of hypertension, diabetes, and obesity predicts a rise in DHF incidence.
  • DHF is characterized by diastolic dysfunction and subtle systolic impairment.

Purpose of the Study:

  • To review clinical trial efforts in diastolic heart failure.
  • To explain discrepancies between clinical trial populations and real-world DHF patients.
  • To propose improvements for future DHF clinical trial design.

Main Methods:

  • Analysis of seven large placebo-controlled trials in DHF.
  • Comparison of patient characteristics in clinical trials versus clinical practice.
  • Review of diagnostic criteria and patient selection in DHF studies.

Main Results:

  • No DHF trials have convincingly demonstrated significant morbidity or mortality reductions.
  • Discordance exists between patients enrolled in trials and those treated in clinical practice.
  • DHF patients are often older with multiple comorbidities, complicating trial outcomes.

Conclusions:

  • Future DHF trials should adhere to strict diagnostic criteria, such as those from the European Study Group on Diastolic Heart Failure.
  • Enrollment should prioritize patients with recent heart failure hospitalizations and significant diastolic dysfunction.
  • Longer trial durations (>3 years) may be necessary but face challenges from competing risks in this older, comorbid population.
Abstract

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