Digoxin After Acute Heart Failure (DIG-DICA)
ConditionAcute Heart Failure (AHF)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-120
SponsorHospital General de Agudos "Dr. Cosme Argerich"
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female ≥ 18 years of age who have signed written informed consent and are willing and able to complete treatment and follow-up.
Recent hospitalization or emergency department visit for decompensated heart failure with reduced ejection fraction (HFrEF) (LVEF ≤ 40%).
Resting heart rate ≥ 60 bpm in patients without a pacemaker.
Distance walked on the 6-minute walk test (6MWT) ≤ 450 meters and/or less than 80% of the predicted value.
Disqualifiers
Resting heart rate < 60 bpm in sinus rhythm or < 70 bpm in atrial fibrillation.
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.
Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m² (based on a sample obtained within the previous month).
Presence of a mechanical ventricular assist device.
Trial design
Design model
Parallel
Treatments tested in this trial
Usual Care
Other interventionStandard clinical care provided according to local practice guidelines. No digoxin or other study-specific medication will be administered.
Digoxin
DrugOral digoxin administered in addition to usual care. Dose selection and adjustments will be based on creatinine clearance using a validated online digoxin dosing calculator according to predefined protocol tables.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Digoxin armExperimental treatment 2 interventions
Group B: Usual care aloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75)
"Well and alive" is defined as the participant being alive and having a quality-of-life score ≥75 on a 0-100 scale at the specified follow-up time point. The primary outcome is the proportion of participants who meet both criteria (alive and QoL ≥75) at 180 days after index hospital discharge.
Time frame
180 daysSponsors and contacts
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Source ClinicalTrials.gov