Actively Recruiting
Digoxin After Acute Heart Failure
Led by Guillermo Liniado · Updated on 2026-01-07
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
G
Guillermo Liniado
Lead Sponsor
H
Hospital General de Agudos "Dr. Cosme Argerich"
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Digoxin After Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older who have signed informed consent and can complete treatment and follow-up
- Recent hospitalization or emergency visit for decompensated heart failure with reduced ejection fraction (LVEF ≤ 40%)
- Resting heart rate of at least 60 bpm in patients without a pacemaker
- 6-minute walk test distance of 450 meters or less and/or less than 80% of predicted value
- NT-proBNP level of at least 450 pg/mL, or at least 900 pg/mL if atrial fibrillation, and/or echocardiographic signs of congestion
You will not qualify if you...
- Resting heart rate below 60 bpm in sinus rhythm or below 70 bpm in atrial fibrillation
- Recent myocardial infarction, acute coronary syndrome, myocarditis, coronary intervention, or device implantation within past 3 months; cardiac surgery or stroke within past 30 days
- Estimated kidney function (eGFR) 30 mL/min/1.73 m² or less
- Presence of mechanical ventricular assist device
- Planned ventricular assist device or heart transplant
- Non-cardiac diseases limiting life expectancy to study duration or preventing 6-minute walk test
- Body mass index 35 kg/m² or higher
- Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy
- Accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome)
- History of symptomatic or sustained ventricular tachyarrhythmia lasting 30 seconds or more
- Intermittent complete or Mobitz type II second-degree AV block without pacemaker or ICD
- Severe aortic valve disease needing invasive treatment
- Complex congenital heart disease
- Known allergy or prior adverse reaction to digoxin
- Current digoxin treatment
- Participation in another clinical trial (except observational registries)
- Pregnant or breastfeeding women or women who may become pregnant during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital General de Agudos Dr Cosme Argerich
Buenos Aires, Buenos Aires F.D., Argentina, 1414
Actively Recruiting
Research Team
G
Guillermo Ernesto Liniado, MD
CONTACT
J
Juan Alberto Gagliardi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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