Digoxin Short Term Treatment Assessment Randomized Trial in AHF

  • STATUS
    Recruiting
  • End date
    Jan 31, 2040
  • participants needed
    1500
  • sponsor
    University of Monastir
Updated on 4 August 2021

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.

Description

AHFS management is challenging given the heterogeniety of the patient population, absence of a universally accepted definition, incomplete understanding of its pathophysiology, and lack of evidence based guidelines.

The majority of patients appear to respond well to initial therapies consisting of loop diuretics and vasoactive agents. however, this treatments failed to decrease post-discharge mortality and readmission rates which represent the most important goal in AHFS.

In the last few years, many drugs has been tested in AHFS setting trying to adress this issue, however results has been disappointing in term of efficacy and / or safety.

Although evidence supports the beneficial effects of digoxin on hemodynamic, neurohormonal, and electrophysiological parameters in patients with CHF, recent publications has rose concerns about its safety profile and therefore decreasing its use.

The effects of digoxin alone or in combination with other vasodilators are seen within few hours of its administration and result in increased cardiac output, decreased pulmonary wedge pressure, increased ejection fraction, and improved neurohormonal profile without changes in blood pressure.

All this findings made us rose the question of whether digoxin is effective or not in short term treatment of acute heart failure ?

Details
Condition Acute Heart Failure
Treatment Placebo, Digoxin
Clinical Study IdentifierNCT02544815
SponsorUniversity of Monastir
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

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
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