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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. NT-proBNP ≥ 450 pg/mL, or ≥ 900 pg/mL in patients with atrial fibrillation, and/or echocardiographic criteria of congestion
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing digoxin for acute heart failure — digoxin is a very old drug, so what do we already know about its safety profile, and are there any specific risks I should be aware of given my current heart condition?
2The main goal of this trial is to measure how many people are both alive and feeling well enough to score 75 or higher on a quality-of-life scale — how is that quality-of-life score actually measured, and is that an outcome that matters most for someone in my situation?
3Since this is a Phase 4 trial, meaning digoxin is already an approved drug being studied further, does that change how much we know about what to expect compared to a trial testing a brand-new treatment?
4Before considering this trial, is there a standard-of-care treatment for my acute heart failure that you'd recommend I try first, and how would that compare to what this study is testing?
5What does participation in this trial actually look like day-to-day — how often would I need to come in for visits, how long would I be followed, and would that be manageable given my current health and home situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants who are "well and alive" (alive and with quality-of-life score ≥75)
Timeframe: 180 days
Trial details
NCT IDNCT07321509
SponsorHospital General de Agudos "Dr. Cosme Argerich"
. 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.
. Planned implantation of a ventricular assist device or cardiac transplantation.
. Non-cardiac comorbidities with a limited life expectancy (less than or equal to the study duration).
. Non-cardiac conditions (neurological or orthopedic) preventing performance of the 6-minute walk test (6MWT).