Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations

Muthiah Vaduganathan, Javed Butler, Lothar Roessig, Gregg C. Fonarow, Stephen J. Greene, Marco Metra, Gadi Cotter, Stuart Kupfer, Andrew Zalewski, Naoki Sato, Gerasimos Filippatos, Mihai Gheorghiade*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF?

Original languageEnglish (US)
Pages (from-to)393-400
Number of pages8
JournalHeart Failure Reviews
Volume20
Issue number4
DOIs
StatePublished - Jul 13 2015

Keywords

  • Clinical trials
  • Heart failure
  • Outcomes
  • Patient selection

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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