Intensive Versus Conventional Digoxin Use in Patients With Heart Failure
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Digoxin was approved for heart failure treatment in 1998 according to current regulations
made by Food and Drug Administration (FDA), based on the following clinical trials: The
Prospective and Randomized Study of Ventricular Function and Efficacy of Digoxin (PROVED),
Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme
(RADIANCE) and Digitalis Investigation Group (DIG). Also, it was approved for the control of
ventricular response rate in atrial fibrillation patients.
Several clinical trials with digoxin provided convincing evidence that support the digoxin
use heart failure (HF) treatment of symptomatic patients. PROVED trial was a
placebo-controlled, twelve weeks duration study. This study included patients with decreased
systolic function, sinus rhythm and heart failure stable symptoms, these patients were using
digoxin and diuretics. Patients whom digoxin was removed presented a twice heart failure
worsen, reduction of exercise capacity and also a reduction of left ventricle ejection
fraction, in comparison to patients that kept the digoxin therapy. The study RADIANCE
followed a similar protocol; however the patients used ACE inhibitors besides digoxin and
diuretics. The digoxin removal was associated with a six times worsen of heart failure,
despite the maintenance of ACE inhibitors and diuretics. There was a worsening in the
functional capacity, life quality and in the ejection fraction on the digoxin removal
patients' group.