Assessing the short-term effects of digoxin in acute heart failure

Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.

This study tests if digoxin can help people with acute heart failure feel better and avoid going back to the hospital after they leave.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Monastir (Academic / other)
• Locations: 2 sites (Hammam sousse, Sousse and 1 other locations)
• Trial ID: NCT02544815 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of digoxin as a short-term treatment for patients with acute heart failure (AHF). It aims to determine whether digoxin can improve patient outcomes, such as cardiac output and reduce readmission rates, compared to a placebo. Participants will be randomized within 12 hours of hospital admission and monitored for their response to the treatment. The study addresses the challenges in managing AHF, particularly the need for effective therapies that can lower post-discharge mortality.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are admitted to the hospital with acute heart failure symptoms and meet specific diagnostic criteria.

Not a fit: Patients with severe renal failure, significant arrhythmias, or those requiring immediate mechanical support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with acute heart failure, potentially improving their recovery and reducing hospital readmissions.

How similar studies have performed: While digoxin has shown beneficial effects in chronic heart failure, its use in acute heart failure settings is less established, making this study a novel investigation.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant or breast feeding women.
* Known severe or terminal renal failure.
* Previous hepatic impairment.
* Major surgery within 30 days.
* Hematocrit \< 25%.
* Alteration of consciousness GCS \< 15
* Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.
* Confirmed or suspected diagnosis of ACS within 45 days before inclusion.
* Severe arrhythmias including significant sinoatrial or atrioventricular blocks or WPW syndrome.
* Implantable cardiac devices including pacemakers and defibrillators.
* Hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
* Noncardiac pulmonary edema, including suspected sepsis.
* Severe pulmonary disease
* Significant stenotic valvular disease .
* Hyperkalemia \> 5.5 mmol /L .
* 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 within 15 days before inclusion or contra-indications to digoxin.
* Inability to follow instructions or comply with follow-up procedures.

Where this trial is running

Hammam sousse, Sousse and 1 other locations

• Sahloul University Hospital — Hammam sousse, Sousse, Tunisia (Recruiting)
• Fattouma Bourguiba University Hospital — Monastir, Tunisia (Recruiting)

Study contacts

• Principal investigator: Nouira Semir, Professor — University Hospital of Monastir
• Study coordinator: Nouira Semir, Professor

Conditions Acute Heart Failure; digoxin, eficacy, safety