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Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel From the Heart Failure

William T Abraham1, Mitchell A Psotka2, Mona Fiuzat3

  • 1Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.

JACC. Heart Failure
|November 17, 2020
PubMed

Insights

The Heart Failure Academic Research Consortium provides consensus recommendations for heart failure (HF) clinical trial design. These guidelines aim to standardize definitions and improve innovation in evaluating HF therapies.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Regulatory Science

Background:

  • Heart failure (HF) requires standardized evaluation methods for therapies.
  • Existing clinical trial designs may benefit from updated consensus definitions.
  • Collaboration between academic investigators, regulatory bodies, and industry is crucial.

Purpose of the Study:

  • To establish consensus definitions and key concepts for evaluating HF therapies.
  • To provide recommendations on optimal medical and device background therapy.
  • To guide clinical trial design elements, statistical concepts, and study endpoints for HF research.

Main Methods:

  • Convening a series of expert panel meetings.
  • Facilitating discussions among leading HF academic investigators, patients, and representatives from regulatory agencies and industry.
  • Synthesizing expert discussions into consensus recommendations.

Main Results:

  • Developed consensus recommendations for HF populations and endpoint definitions.
  • Addressed optimal medical and device background therapy considerations.
  • Provided insights into clinical trial design and statistical concepts.

Conclusions:

  • The recommendations aim to stimulate innovation in HF clinical trial design.
  • Standardized definitions and concepts are essential for robust HF therapy evaluation.
  • This work serves as a foundation for future HF research and drug development.

Keywords:
Clinical trialDefinitionsEndpointsHeart failure

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