Low-dose digoxin after an episode of acute heart failure

Digoxina After Acute Hearte Failure

This study tests whether adding low-dose digoxin to standard heart failure medicines helps adults with reduced ejection fraction who recently stabilized after hospitalization feel better and be 'Alive and Well' at 180 days.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Hospital General de Agudos "Dr. Cosme Argerich" (Academic / other)
• Locations: 1 site (Buenos Aires, Buenos Aires F.D.)
• Trial ID: NCT07321509 on ClinicalTrials.gov

What this trial studies

DIG-DICA is a randomized, controlled, open-label, single-center trial that enrolls adults with HFrEF who recently stabilized after hospitalization or urgent care for acute decompensation. Participants are randomized to usual care alone or usual care plus low-dose digoxin with dosing aimed at low therapeutic serum concentrations. The primary outcome is the proportion of patients who are "Alive and Well" at 180 days, defined by a KCCQ-12 score ≥75, and secondary outcomes include symptoms, 6-minute walk distance, NT-proBNP, renal function, and major cardiovascular events. The trial seeks to clarify whether contemporary low-dose digoxin provides meaningful clinical and quality-of-life benefits when added to guideline-directed medical therapy.

Who should consider this trial

Good fit: Adults (≥18) with HFrEF (LVEF ≤40%) who were recently hospitalized or treated for acute decompensation, have stabilized on guideline-directed medical therapy, meet resting heart rate and 6-minute walk/NT-proBNP thresholds, and can complete follow-up are ideal candidates.

Not a fit: Patients with low resting heart rates (sinus rhythm <60 bpm or AF <70 bpm), very recent myocardial infarction, recent implantation of CRT/PM/ICD or recent cardiac surgery/stroke, or those without reduced ejection fraction are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, adding low-dose digoxin could increase the number of patients who are symptomatically well and improve quality of life in the 6 months after an acute heart failure episode.

How similar studies have performed: Older trials of digoxin (e.g., DIG) showed reduced hospitalizations but no mortality benefit, and contemporary evidence for low-dose digoxin after acute decompensation is limited.

Eligibility criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age who have signed written informed consent and are willing and able to complete treatment and follow-up.
2. Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%).
3. Resting heart rate ≥ 60 bpm in patients without a pacemaker.
4. Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value.
5. NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion

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Exclusion Criteria:

1. Resting heart rate \< 60 bpm in sinus rhythm or \< 70 bpm in atrial fibrillation.
2. Myocardial infarction, acute coronary syndrome, myocarditis, percutaneous coronary intervention, or recent implantation (within the past 3 months) of cardiac resynchronization therapy (CRT), pacemaker, or implantable cardioverter-defibrillator (ICD); cardiac surgery or stroke within the past 30 days.
3. Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month).
4. Presence of a mechanical ventricular assist device.
5. Planned implantation of a ventricular assist device or cardiac transplantation.
6. Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration).
7. Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT).
8. Body mass index (BMI) ≥ 35 kg/m².
9. Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy.
10. Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome).
11. History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds).
12. Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD.
13. Severe aortic valvular disease (grade III/III) with indication for invasive treatment.
14. Complex congenital heart disease.
15. Known hypersensitivity to digoxin (including prior adverse reactions).
16. Current treatment with digoxin.
17. Participation in another clinical trial (excluding observational registries).
18. Pregnant or breastfeeding women, or women with the potential to become pregnant during the study period.

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Where this trial is running

Buenos Aires, Buenos Aires F.D.

• Hospital General de Agudos Dr Cosme Argerich — Buenos Aires, Buenos Aires F.D., Argentina (Recruiting)

Study contacts

• Study coordinator: Guillermo Ernesto Liniado, MD

Conditions Acute Heart Failure; Systolic Heart Failure; Digoxin; Quality of Life