drugset / Trial / NCT07321509

Digoxin After Acute Heart Failure (DIG-DICA)

NCT07321509

Phase 4 Recruiting 120 enrolled Hospital General de Agudos "Dr. Cosme Argerich"
RandomizedParallel-groupOpen-labelTreatment

Summary

The DIG-DICA trial is a randomized, controlled, open-label, single-center study designed to evaluate whether adding low-dose digoxin to optimal medical therapy after an episode of acute decompensated heart failure improves patients' clinical status and quality of life. The study enrolls adults with heart failure with reduced ejection fraction (HFrEF) who have recently stabilized after hospitalization or urgent care for decompensation. The primary aim is to determine whether digoxin increases the proportion of patients who are "Alive and Well" at 180 days-defined by achieving a Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score ≥75. The trial also explores effects on symptoms, functional capacity, biomarkers, renal function, and major cardiovascular events. The goal is to clarify whether modern low-dose digoxin provides meaningful clinical benefit in contemporary heart failure management.

Timeline

Start
2025-12-16
Primary completion
2027-12-16
Completion
2028-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified Oral

Indications