Long-Term Results of the Spanish Trial on Treatment and Survival of Patients with Predominantly Mild Heart Failure

• Published in: Journal of cardiovascular pharmacology Vol. 33; no. 5; pp. 733 - 740
• Main Authors: Cosín-Aguilar, J, Marrugat, J, Sanz, G, Massó, J, Gil, M, Vargas, R, Pérez-Casar, F, Simarro, E, De Armas, D, García-García, J, Azpitarte, J, Diago, J L, Rodrigo-Trallero, G, Lekuona, I, Domingo, E, Marin-Huerta, E
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Lippincott Williams & Wilkins, Inc 01-05-1999; Hagerstown, MD Lippincott
• Subjects: Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors - adverse effects; Angiotensin-Converting Enzyme Inhibitors - therapeutic use; Biological and medical sciences; Captopril - adverse effects; Captopril - therapeutic use; Cardiac Output, Low - diagnostic imaging; Cardiac Output, Low - drug therapy; Cardiac Output, Low - mortality; Cardiac Output, Low - physiopathology; Cardiotonic Agents - adverse effects; Cardiotonic Agents - therapeutic use; Cardiovascular system; Digoxin - adverse effects; Digoxin - therapeutic use; Diuretics - adverse effects; Diuretics - therapeutic use; Drug Therapy, Combination; Exercise Test; Female; Humans; Male; Medical sciences; Middle Aged; Miscellaneous; Pharmacology. Drug treatments; Quality of Life; Spain; Survival Analysis; Ultrasonography; Human; Heart failure; Drug combination; Cardiotonic agent; Digoxin; Captopril; Treatment efficiency; Mortality; Cardiovascular disease; Long term; Survival; Quality of life; Diuretic; Chemotherapy; Randomization; Treatment; Heart disease; Antihypertensive agent; Glycoside; Digitalis drug; Comparative study; ACE inhibitor
• ISSN: 0160-2446; 1533-4023
• DOI: 10.1097/00005344-199905000-00009

A randomized open-label clinical trial was conducted to determine whether mortality, readmission, or quality of life differed between heart failure patients managed with captopril plus diuretics and those with digoxin plus diuretics. A total of 345 heart failure patients in New York Heart Association functional classes 2 and 3 without atrial fibrillation, dyspnea of bronchopulmonary origin, or hypertension not controlled with diuretics was randomized for digoxin (n = 175) or captopril (n = 170) treatment and followed up for a median of 4.5 years. Socioeconomic, demographic, electrocardiographic, echocardiographic, spirometric, and chest radiograph data were obtained at the initial examination. In a random sample of half the patients, ergometric, echocardiographic, and Holter records were obtained at entry and at 3 and 18 months. Patients were followed up for ≥3 years. The end points were mortality, hospitalization for cardiac events, deterioration 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 clinical point of view, only the 48-month mortality was relevantly lower (20.9 vs. 31.9%, respectively) among patients treated with captopril than that in those receiving digoxin (log rank test, p = 0.07). No statistically or clinically relevant differences were found in other end points or adverse effects. 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.