Can an old heart drug help patients bounce back after a crisis?
NCT ID NCT07321509
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a low dose of digoxin to usual heart failure treatments helps people feel better and live well after a recent hospital visit for worsening heart failure. About 120 adults with weak heart pumping function will take digoxin or continue their current care. The main goal is to see if more patients are alive and report good quality of life six months later.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \- 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital General de Agudos Dr Cosme Argerich
RECRUITINGBuenos Aires, Buenos Aires F.D., 1414, Argentina
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Other studies related to the condition(s) this trial covers.
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