Measurement of end points in heart failure trials: jousting at windmills?
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.
Hauptman
Paul J
PJ
Division of Cardiology and Department of Medicine, Saint Louis University School of Medicine, Saint Louis, MO, USA. hauptmpj@slu.edu
D035843:Biomedical Research / Q000379:methods; D002423:Cause of Death; D002908:Chronic Disease; D023381:Endpoint Determination; D006333:Heart Failure / Q000188:drug therapy / Q000401:mortality*; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013997:Time Factors