search
Back to results

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

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Digoxin
Placebo
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure focused on measuring digoxin, eficacy, safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sahloul University HospitalRecruiting
  • Fattouma Bourguiba University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Digoxin

Placebo

Arm Description

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

Oral placebo for three days.

Outcomes

Primary Outcome Measures

30 days mortality and rehospitalization rate

Secondary Outcome Measures

Hemodynamic improvement
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.
Need for hospitalization
Length of stay in hospital
AUC of dyspnea VAS scores
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.
Improvement of patient-reported dyspnea
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.
Dyspnea resolution time
defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline.
Digoxin related adverse events
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).
Worsening renal function
worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value.

Full Information

First Posted
September 5, 2015
Last Updated
June 17, 2023
Sponsor
University of Monastir
search

1. Study Identification

Unique Protocol Identification Number
NCT02544815
Brief Title
Digoxin Short Term Treatment Assessment Randomized Trial in AHF
Acronym
DIG-STA-AHF
Official Title
Assessment of the Efficacy and Safety of a Short Term Treatment With Digoxin on Patients With Acute Heart Failure Syndromes. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
digoxin, eficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digoxin
Arm Type
Active Comparator
Arm Description
Oral digoxin 0.25 mg: one pill per day for three consecutive days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo for three days.
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Description
Digoxin 0.25 mg pills
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pills
Primary Outcome Measure Information:
Title
30 days mortality and rehospitalization rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Hemodynamic improvement
Description
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.
Time Frame
3 days
Title
Need for hospitalization
Time Frame
3 days
Title
Length of stay in hospital
Time Frame
from baseline to hospital discharge
Title
AUC of dyspnea VAS scores
Description
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.
Time Frame
3 days
Title
Improvement of patient-reported dyspnea
Description
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
[Time Frame: 6, 12, and 24 hours from start of the study medication]
Title
Dyspnea resolution time
Description
defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline.
Time Frame
3 days
Title
Digoxin related adverse events
Description
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).
Time Frame
30 days
Title
Worsening renal function
Description
worsening renal function under treatment is defined as a relative increase in serum creatinine of at least 25% from baseline value.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouira Semir, Professor
Phone
73106000
Ext
00216
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Bzeouich Nasri, MD
Phone
52919170
Ext
00216
Email
medecinasri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Organizational Affiliation
University Hospital of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahloul University Hospital
City
Hammam sousse
State/Province
Sousse
ZIP/Postal Code
4011
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boukef Riadh, Professor
Phone
73460678
Ext
00216
Email
riadh.boukef@rnu.tn
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Phone
73641144
Ext
00216
Email
semir.nouira@rnu.tn
First Name & Middle Initial & Last Name & Degree
nasri Bzeouich, MD
Phone
52919170
Ext
00216
Email
medecinasri@gmail.com
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
First Name & Middle Initial & Last Name & Degree
Beltaief Kaouthar, MD
First Name & Middle Initial & Last Name & Degree
Bzeouich Nasri, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16365214
Citation
Gheorghiade M, Zannad F, Sopko G, Klein L, Pina IL, Konstam MA, Massie BM, Roland E, Targum S, Collins SP, Filippatos G, Tavazzi L; International Working Group on Acute Heart Failure Syndromes. Acute heart failure syndromes: current state and framework for future research. Circulation. 2005 Dec 20;112(25):3958-68. doi: 10.1161/CIRCULATIONAHA.105.590091. No abstract available.
Results Reference
background
PubMed Identifier
9036306
Citation
Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33. doi: 10.1056/NEJM199702203360801.
Results Reference
background
PubMed Identifier
24067296
Citation
Hashim T, Elbaz S, Patel K, Morgan CJ, Fonarow GC, Fleg JL, McGwin G, Cutter GR, Allman RM, Prabhu SD, Zile MR, Bourge RC, Ahmed A. Digoxin and 30-day all-cause hospital admission in older patients with chronic diastolic heart failure. Am J Med. 2014 Feb;127(2):132-9. doi: 10.1016/j.amjmed.2013.08.006. Epub 2013 Sep 23.
Results Reference
background

Learn more about this trial

Digoxin Short Term Treatment Assessment Randomized Trial in AHF

We'll reach out to this number within 24 hrs