Long-term results of the Spanish trial on treatment and survival of patients with predominantly mild heart failure

A randomized open-label clinical trial was conducted to determine whether m ortality, readmission, or quality of life differed between heart failure pa tients managed with captopril plus diuretics and those with digoxin plus di uretics. A total of 345 heart failure patients in New York Heart Associatio n functional classes 2 and 3 without atrial fibrillation, dyspnea of bronch opulmonary origin, or hypertension not controlled with diuretics was random ized for digoxin (n = 175) or captopril (n = 170) treatment and followed up for a median of 4.5 years. Socioeconomic, demographic, electrocardiographi c, echocardiographic, spirometric, and chest radiograph data were obtained at the initial examination. In a random sample of half the patients, ergome tric, echocardiographic, and Holter records were obtained at entry and at 3 and 18 months. Patients were followed up for greater than or equal to 3 ye ars. The end points were mortality, hospitalization for cardiac events, det erioration in quality of life, worsening of functional class, and need for digoxin or captopril in the captopril and digoxin groups, respectively. The trial had to be terminated prematurely owing to the difficulty in finding candidates free of angiotensin-converting enzyme (ACE)-inhibitor treatment. Baseline patient characteristics were similar in both groups. From the cli nical point of view, only the 48-month mortality was relevantly lower (20.9 vs. 31.9%, respectively) among patients treated with captopril than that i n those receiving digoxin (log rank test, p = 0.07). No statistically or cl inically relevant differences were found in other end points or adverse eff ects. The results suggest but do not confirm the hypothesis that captopril treatment in mild to moderate heart failure might provide better long-term survival than digoxin.