Validity of the minnesota living with heart failure questionnaire as a measure of therapeutic response to enalapril or placebo

Patients' perspectives concerning the effects of disease and therapy on their lives have become increasingly important for the assessment of medications in clinical trials. The Minnesota Living with Heart Failure (LIhiFE) questionnaire was developed to systematically and comprehensively assess the patient's perceptions of the effects of heart failure, and its treatment on his or her daily life.1 A valid measure of therapeutic response should be responsive to medications known to benefit patients with heart failure and be insensitive to the effects of placebo. In addition, a valid measure would indicate that patients with overt heart failure have more impairment than do those with left ventricular dysfunction who do not need medications for heart failure. We previously showed that this questionnaire was sensitive to the effects of pimobendan, an inotropic agent with vasodilator properties, and was insensitive to placebo in patients with moderate-to-severe heart failure.2,3 This report demonstrates the questionnaire's responsiveness to a converting enzyme inhibitor and confirms its insensitivity to placebo.