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New treatment option for Acute Heart Failure (AHF)
Official title Digoxin After Acute Heart Failure (DIG-DICA)
ClinicalTrials.gov ID: NCT07321509
What this study is testing
What is Digoxin?
Digoxin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute heart failure (ahf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- 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 \-
You likely can't join if
- 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...
- 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).
See the full eligibility 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 \-
- 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...
- 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).
- Body mass index (BMI) ≥ 35 kg/m².
- Amyloid, hypertrophic obstructive, or constrictive cardiomyopathy.
- Presence of an accessory atrioventricular conduction pathway (e.g., Wolff-Parkinson-White syndrome).
- History of symptomatic or sustained ventricular tachyarrhythmia (≥ 30 seconds).
- Intermittent complete atrioventricular block or Mobitz type II second-degree AV block without pacemaker or ICD.
- Severe aortic valvular disease (grade III/III) with indication for invasive treatment.
- Complex congenital heart disease.
- Known hypersensitivity to digoxin (including prior adverse reactions).
- Current treatment with digoxin.
- Participation in another clinical trial (excluding observational registries).
- Pregnant or breastfeeding women, or women with the potential to become pregnant during the study period. \-
The study team makes the final eligibility decision.
Where it's taking place
- Buenos Aires, Buenos Aires F.D., Argentina
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buenos Aires, Buenos Aires F.D., Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.