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

December 11, 2023 updated by: Pr. Semir Nouira, University of Monastir

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Monastir, Tunisia, 5000
        • Recruiting
        • Fattouma Bourguiba University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nouira Semir, Professor
        • Sub-Investigator:
          • Beltaief Kaouthar, MD
        • Sub-Investigator:
          • Bzeouich Nasri, MD
    • Sousse
      • Hammam sousse, Sousse, Tunisia, 4011
        • Recruiting
        • Sahloul University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Digoxin
Oral digoxin 0.25 mg: one pill per day for 30 consecutive days.
Digoxin 0.25 mg pills
Placebo Comparator: Placebo
Oral placebo for 30 days.
Placebo pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30 days mortality and rehospitalization rate
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic improvement
Time Frame: 3 days
Change in hemodynamic parameters as quantified by the area under the curve of bio-impedance thoracic fluid contenant (TFC), lung ultrasound (LUS) congestion score and BNP serum levels, from baseline to day 3.
3 days
Need for hospitalization
Time Frame: 3 days
3 days
Length of stay in hospital
Time Frame: from baseline to hospital discharge
from baseline to hospital discharge
Improvement of patient-reported dyspnea
Time Frame: [Time Frame: 6, 12, and 24 hours from start of the study medication]
Improvement of patient-reported dyspnea relative to the start of study drug using a 5 point likert scale at 6, 12, and 24 hours, where a responder was a patient with better or markedly betted dyspnea at all three of those time points.
[Time Frame: 6, 12, and 24 hours from start of the study medication]
Dyspnea resolution time
Time Frame: 3 days
defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline.
3 days
Digoxin related adverse events
Time Frame: 30 days

Occurrence of major adverse events related to digoxin and implicating its discontinuation.

Admitted major side effects of digoxin are: Severe ventricular arrhythmias including ventricular tachycardia or fibrillation, Severe bradycardia, Second- or third-degree heart block not responsive to atropine, Serum potassium levels exceeding 5.5 mEq/L with rapidly progressive signs and symptoms of digoxin toxicity, Neurologic symptoms (eg, visual disturbances, disorientation, and confusion).

30 days
Worsening renal function
Time Frame: 30 days
worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value.
30 days
AUC of dyspnea VAS scores
Time Frame: 3 days
Change in patient-reported dyspnea as quantified by the area under the curve (AUC) of visual analogue scale (VAS) scores (0-100 mm scale) : a dyspnea VAS score of 0 corresponds to the patient's subjective feeling of "I Can Breathe Normally" and a dyspnea VAS score of 100 corresponds to "I Can't Breathe At All.
3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digoxin related adverse events
Time Frame: from administration of study drug to 30 days after

Occurrence of major adverse events related to digoxin and implicating its discontinuation.

Admitted major side effects of digoxin are: Severe ventricular arrhythmias including ventricular tachycardia or fibrillation, Severe bradycardia, Second- or third-degree heart block not responsive to atropine, Serum potassium levels exceeding 5.5 mEq/L with rapidly progressive signs and symptoms of digoxin toxicity, Neurologic symptoms (eg, visual disturbances, disorientation, and confusion).

from administration of study drug to 30 days after
Worsening renal function
Time Frame: from administration of study drug to 30 days after

Worsening of renal function rates within day 30 from starting of the study treatment.

Worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value.

from administration of study drug to 30 days after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nouira Semir, Professor, University Hospital of Monastir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

September 5, 2015

First Submitted That Met QC Criteria

September 5, 2015

First Posted (Estimated)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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