Digoxin Short Term Treatment Assessment Randomized Trial in AHF

• Status: Recruiting
• Trial end date: 2040-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Monastir
• Treatments: Digoxin

Criteria

Inclusion Criteria:

• Able to provide informed written consent.

• Male or female aged ≥18 years old.

• Admitted for AHFS.

• 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.

• 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.