Development and testing of a new measure of health status for clinical trials in heart failure.

The authors developed a new measure of subjective health status for patients with heart failure. Eighty-eight patients with heart failure were asked about the impact of their condition on 123 items related to physical and emotional function. The most frequently chosen and important items were included in a 16-item Chronic Heart Failure Questionnaire (CHQ) that examines dyspnea during daily activities, fatigue, and emotional function. The CHQ was tested in a controlled trial of digoxin in heart failure patients in sinus rhythm. When administered serially to 25 patients in the run-in phase of the trial, the CHQ proved reproducible. Subsequently, CHQ results distinguished those who reported improvement or deterioration from those who did not. The CHQ showed moderate correlations with patient global ratings, walk test scores, and clinical assessments of heart failure. The authors conclude that the CHQ may be useful for measuring health status in clinical trials in heart failure.