Digoxin Short Term Treatment Assessment Randomized Trial in AHF (DIG-STA-AHF)

University of Monastir

Status and phase: Enrolling; Phase 3

Conditions: Acute Heart Failure

Treatments: Drug: Placebo; Drug: Digoxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02544815

Digoxin - START - AHF

Details and patient eligibility

About

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.

Full 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 ? Additionnel treatments for AHF were given according left to ACCF/AHA for the managementof heart failure .

Blood testing for scanner digoxin magerments will be confirmed at H8, h24 and H72 after the post protocol treatment admession treatment administration.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

500 participants in 2 patient groups, including a placebo group

Digoxin

Active Comparator group

Description:

Oral digoxin 0.25 mg: one pill per day for 30 consecutive days.

Treatment:

Drug: Digoxin

Placebo

Placebo Comparator group

Description:

Oral placebo for 30 days.

Treatment:

Drug: Placebo