Phase III clinical trial end points in acute heart failure syndromes: A virtual roundtable with the acute heart failure syndromes international working group

[...]both patient selection and end points should be drug or class specific. Several issues still need to be addressed in AHFS trial design: better understanding of its pathophysiology, patient selection (eg, homogeneous populations in terms of clinical profile and pathophysiology); this, however, m...

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Bibliographic Details
Published in:The American heart journal 2009-06, Vol.157 (6), p.957-970
Main Authors: Gheorghiade, Mihai, MD, Adams, Kirkwood F., MD, Cleland, John G.F., MD, Cotter, Gad, MD, Felker, G. Michael, MD, MHS, Filippatos, Gerasimos S., MD, Fonarow, Gregg C., MD, Greenberg, Barry H., MD, Hernandez, Adrian F., MD, MHS, Khan, Sadiya, BS, Komajda, Michel, MD, Konstam, Marvin A., MD, Liu, Peter P., MD, Maggioni, Aldo P., MD, Massie, Barry M., MD, McMurray, John J., MD, Mehra, Mandeep, MD, Metra, Marco, MD, O'Connell, John, MD, O'Connor, Christopher M., MD, Pang, Peter S., MD, Piña, Ileana L., MD, Sabbah, Hani N., PhD, Teerlink, John R., MD, Udelson, James E., MD, Yancy, Clyde W., MD, Zannad, Faiez, MD, PhD, Stockbridge, Norman, MD, PhD
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Acute Disease
Biomarkers
Cardiovascular
Cardiovascular disease
Clinical trials
Clinical Trials, Phase III as Topic
Confidence intervals
Drug therapy
Electronic Mail
Heart failure
Heart Failure - mortality
Heart Failure - therapy
Hospitalization
Humans
Intervention
Likert scale
Meetings
Mortality
Patients
Regulatory approval
Surveys and Questionnaires
Treatment Outcome
Citations: Items that cite this one
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Summary:[...]both patient selection and end points should be drug or class specific. Several issues still need to be addressed in AHFS trial design: better understanding of its pathophysiology, patient selection (eg, homogeneous populations in terms of clinical profile and pathophysiology); this, however, may limit enrollment and/or marketing incentives, preventing cardiac and kidney injury during or soon after the intervention, identifying clinically meaningful end points (eg, composite end points, global ranking method) since the acceptable level of risk (safety) for approval will depend on the benefit of the therapeutic intervention.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2009.04.010