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

Who is this study for? Patients with Acute Heart Failure
What treatments are being studied? Digoxin
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Tunisia
Sahloul University Hospital
RECRUITING
Hammam Sousse
Fattouma Bourguiba University Hospital
RECRUITING
Monastir
Contact Information
Primary
Nouira Semir, Professor
semir.nouira@rns.tn
73106000
Backup
Bzeouich Nasri, MD
medecinasri@gmail.com
52919170
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 500
Treatments
Active_comparator: Digoxin
Oral digoxin 0.25 mg: one pill per day for 30 consecutive days.
Placebo_comparator: Placebo
Oral placebo for 30 days.
Related Therapeutic Areas
Sponsors
Leads: University of Monastir

This content was sourced from clinicaltrials.gov