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Can an old heart drug help patients bounce back after a crisis?

NCT ID NCT07321509

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 120 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital General de Agudos Dr Cosme Argerich

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1414, Argentina

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