Actively Recruiting
Evaluation of Digoxin Therapy in Patients With Heart Failure After Acute Decompensation
Led by Hospital General de Agudos "Dr. Cosme Argerich" · Updated on 2026-06-02
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding low-dose digoxin to standard medical treatment improves the clinical status and quality of life for adults with heart failure with reduced ejection fraction (HFrEF) who have recently stabilized after an acute episode. This randomized, controlled, open-label study focuses on patients who were hospitalized or treated urgently for heart failure decompensation. The main goal is to see if digoxin increases the proportion of patients who are "Alive and Well" at 180 days, based on a quality-of-life questionnaire score. Participants are randomly assigned to receive either usual care alone or usual care plus low-dose oral digoxin. Digoxin dosing is carefully adjusted using a web-based calculator based on kidney function to keep levels low and consistent with safety guidelines. The study compares these two groups over a period of 180 days following stabilization after acute heart failure. During the study, participants will undergo assessments including quality-of-life questionnaires, symptom evaluations, and functional capacity tests like the 6-minute walk test. Researchers will also measure biomarkers related to heart failure and kidney function and track major cardiovascular events such as hospitalizations or urgent care visits. The study aims to provide evidence on the role of low-dose digoxin in modern heart failure management and will last for at least 180 days of follow-up after enrollment.
CONDITIONS
Brief Title
Digoxin After Acute Heart Failure (DIG-DICA)
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% or less)
- Resting heart rate 60 bpm or higher in patients without a pacemaker
- Able to walk 450 meters or less, or less than 80% of predicted value, on the 6-minute walk test
- NT-proBNP level 450 pg/mL or higher, or 900 pg/mL or higher in patients with atrial fibrillation, or signs of congestion on echocardiogram
You will not qualify if you...
- Resting heart rate below 60 bpm in sinus rhythm or below 70 bpm in atrial fibrillation
- Recent heart attack, acute coronary syndrome, myocarditis, cardiac surgery, or implantation of CRT, pacemaker, or ICD within past 3 months (30 days for surgery or stroke)
- Estimated kidney function (eGFR) 30 mL/min/1.73 m² or less
- Presence of a mechanical ventricular assist device
- Planned ventricular assist device implantation or heart transplant
- Non-cardiac illnesses with life expectancy less than or equal to study duration
- Neurological or orthopedic conditions preventing performance of 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 sustained ventricular tachyarrhythmia lasting 30 seconds or longer
- Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD
- Severe aortic valve disease requiring invasive treatment
- Complex congenital heart disease
- Known allergy or prior adverse reaction to digoxin
- Current use of digoxin
- Participation in another clinical trial except observational registries
- Pregnant or breastfeeding women, or women who may become pregnant during the study period
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 180 days
Participants receive either usual care alone or low-dose digoxin in addition to their standard therapy after stabilization from acute heart failure.
Regular visits during treatment for dose adjustments and assessments
Duration - Up to 180 days following treatment initiation
Participants are monitored for clinical status, symptoms, and quality of life after completion of treatment.
Periodic visits to assess clinical outcomes and patient-reported measures
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
J
Juan Alberto Gagliardi, MD
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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