NCT02544815CompletedPhase 3
Digoxin Short Term Treatment Assessment Randomized Trial in AHF
Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
AHFS management is challenging and most of the used drugs has failed to decrease post-discharge mortality and readmission rates which represent the most important goal in AHFS. Digoxin processes many characteristics of a beneficial drug for heart failure, however recent publications has rose concerns about its safety profile and therefore decreasing its use. Whether digoxin is efficient and safe in short term treatment of acute heart failure is a question that should be studied.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- First submitted
- 5 Sept 2015
- Start date
- 1 May 2023
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University of Monastir
- Diseases
- Heart failure
- NCT number
- NCT02544815
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 500
- From 1 May 2023 to the primary completion date, 31 Aug 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 30 days.
- Confirmed or suspected diagnosis of ACS within 45 days before inclusion.
- Administration of an investigational drug or implantation of an investigational device or participation in another trial within 30 days before screening.
- Previous treatment with digoxin before inclusion or contra-indications to digoxin.
Other illness
- Known severe or terminal renal failure.
- Severe hepatic impairment.
- Severe arrhythmias including significant sinoatrial or atrioventricular blocks or WPW syndrome.
- Implantable cardiac devices including pacemakers and defibrillators.
- Severe pulmonary disease
- Significant stenotic valvular disease .
Other
- Pregnant or breast feeding women.
- Hematocrit \< 25%.
- Alteration of consciousness GCS \< 15
- Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.
- Hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
- Noncardiac pulmonary edema, including suspected sepsis.
- Hyperkalemia \> 5.5 mmol /L .
- Inability to follow instructions or comply with follow-up procedures.
Who the study is looking for
- Able to provide informed written consent.
- Male or female aged ≥18 years old.
- Admitted for acute heart failure defined by the presence of dypnea at rest or with minimal exertion , pulmonary congestion on chest radiograph ; and increased natriutic peptide concentrations ( BNP \>=350 pg/ml) or NTproBNP \>=1400 pg/ml ) .
- Able to be randomized within 12 hours from presentation to the hospital.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahloul University Hospital Coordinator of this site? Confirm its status | Hammam Sousse | Tunisia | Unknown status |
| Fattouma Bourguiba University Hospital Coordinator of this site? Confirm its status | Monastir | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.