End Points for Clinical Trials in Acute Heart Failure Syndromes

Acute heart failure syndromes (AHFS) remain a major cause of morbidity and mortality, in part because the development of new therapies for these disorders has been marked by frequent failure and little success. The heterogeneity of current approaches to AHFS drug development, particularly with regar...

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Bibliographic Details
Published in:Journal of the American College of Cardiology 2009-06, Vol.53 (24), p.2248-2258
Main Authors: Allen, Larry A., MD, MHS, Hernandez, Adrian F., MD, MHS, O'Connor, Christopher M., MD, Felker, G. Michael, MD, MHS
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Acute Disease
acute heart failure syndromes/acute decompensated heart failure
Cardiology
Cardiotonic Agents - therapeutic use
Cardiovascular
Clinical trials
Disease Progression
Drug therapy
end points
Endpoint Determination
Heart failure
Heart Failure - drug therapy
Heart Failure - mortality
Hemodynamics
Hospitals
Humans
Internal Medicine
Length of Stay
Mortality
Patients
Public health
Pulmonary arteries
randomized controlled trial design
Randomized Controlled Trials as Topic - methods
Regulatory approval
Syndrome
United States
United States Food and Drug Administration
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Summary:Acute heart failure syndromes (AHFS) remain a major cause of morbidity and mortality, in part because the development of new therapies for these disorders has been marked by frequent failure and little success. The heterogeneity of current approaches to AHFS drug development, particularly with regard to end points, remains a major potential barrier to progress in the field. End points involving hemodynamic status, biomarkers, symptoms, hospital stay, end organ function, and mortality have all been employed either alone or in combination in recent randomized clinical trials in AHFS. In this review, we will discuss the various end point domains from both a clinical and a statistical perspective, summarize the wide variety of end points used in completed and ongoing AHFS studies, and suggest steps for greater standardization of end points across AHFS trials.
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2008.12.079