Measurement of end points in heart failure trials: Jousting at windmills?

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Advances in the treatment of congestive heart failure, a condition of increasing incidence and prevalence, have been made possible by knowledge gained from randomized clinical trials. The selection of end points in these trials has become a pivotal step in the drug and device approval process. In part because of the success of earlier trials, the number of study subjects required in order to realize an important improvement in survival has increased. This has led to the development of alternative combined and composite end points, often including surrogates for mortality. The limitations of these end points, the specific challenges associated with studies of patients with decompensated and diastolic heart failure, and other issues encountered during and after completion of heart failure trials, are discussed.

Original languageEnglish (US)
Pages (from-to)298-304
Number of pages7
JournalMount Sinai Journal of Medicine
Volume71
Issue number5
StatePublished - Oct 1 2004

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Device Approval
Heart Failure
Diastolic Heart Failure
Drug Approval
Randomized Controlled Trials
Survival
Mortality
Incidence
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Measurement of end points in heart failure trials : Jousting at windmills? / Hauptman, Paul J.

In: Mount Sinai Journal of Medicine, Vol. 71, No. 5, 01.10.2004, p. 298-304.

Research output: Contribution to journalArticle

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