Volume 71 Number 5 October 2004	back to contents

From the Division of Cardiology and Department of Medicine, Saint Louis University School of Medicine, Saint Louis, MO.

Address all correspondence to Paul J. Hauptman, M.D., Heart Failure and Transplantation Section, Saint Louis University Hospital, FDT-15, 3635 Vista Avenue, Saint Louis, MO 63110; E-mail: hauptmpj@slu.edu

Presented in part at a Cardiology Grand Rounds presentation to the Department of Medicine, Mount Sinai School of Medicine, New York, NY, on February 4, 2002, and updated as of June 2004.

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.

KEY WORDS
Heart failure, end points, clinical trials.

MSSM Home

Back Issues | Indexes | Search | Journal Home