Moving towards a novel paradigm in drug development for worsening heart failure: The t1 model (mechanistic translational phase)

Sadiya Sana Khan, Mihai Gheorghiade, Gerasimos Filippatos*

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Hospitalization for worsening heart failure (WHF) represents a clinical entity with high burden of global disease, unacceptable postdischarge mortality and rehospitalization rates reaching 45% within 60-90 days, and enormous economic expenditures worldwide. Despite the use of evidence-based therapies and implementation of policy measures on the governmental level, there has been minimal impact on the event rate following hospitalization for worsening heart failure over the past decade. In addition, the aging population and improved survival post-myocardial infarction will continue to fuel the growing population of patients with heart failure. There exists a substantial unmet need for novel therapeutic strategies that will improve outcomes in patients hospitalized with WHF. The current paradigm of sequentially conducting trials from phase I to III has not resulted in successful identification of therapies that improve outcomes and a different approach is needed. Herein we describe potential reasons for the failure of current phase III clinical trails, lessons learned, and outline the T1 or translational phase model as a novel paradigm to move forward to successfully develop drug development in patients hospitalized with WHF.

Original languageEnglish (US)
Title of host publicationIntroduction to Translational Cardiovascular Research
PublisherSpringer International Publishing
Pages583-593
Number of pages11
ISBN (Electronic)9783319087986
ISBN (Print)9783319087979
DOIs
StatePublished - Jan 1 2015

Keywords

  • Clinical Trials
  • Heart Failure
  • Translational Phase Models
  • Worsening Heart Failure

ASJC Scopus subject areas

  • Medicine(all)

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