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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02544815
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pr. Semir Nouira, University of Monastir

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.


Condition or disease Intervention/treatment Phase
Acute Heart Failure Drug: Digoxin Drug: Placebo Phase 3

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 ?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 31, 2040
Estimated Study Completion Date : January 31, 2040

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Digoxin

Arm Intervention/treatment
Active Comparator: Digoxin
Oral digoxin 0.25 mg: one pill per day for three consecutive days.
Drug: Digoxin
Digoxin 0.25 mg pills

Placebo Comparator: Placebo
Oral placebo for three days.
Drug: Placebo
Placebo pills




Primary Outcome Measures :
  1. AUC of dyspnea VAS scores [ Time Frame: from baseline to day 3 ]
    Change in patient-reported dyspnea as quantified by the area under the curve (AUC) of visual analogue scale (VAS) scores (0-100 mm scale) from baseline to day 3.

  2. Improvement of patient-reported dyspnea [ 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.

  3. Dyspnea resolution time [ Time Frame: from baseline to day 3 ]
    Dyspnea resolution time is defined as the time between the start of study drug and the reduction of at least 50% of the dyspnea VAS score from baseline.


Secondary Outcome Measures :
  1. Hemodynamic improvement [ Time Frame: from baseline to day 3 ]
    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.

  2. Need for hospitalization [ Time Frame: day 3 ]
    The need for hospitalization after 3 days of ED care.

  3. In-hospital length of stay [ Time Frame: from baseline to hospital discharge ]
    In-hospital length of stay measured from randomization to hospital discharge.

  4. Death or readmission rates [ Time Frame: within 30 days from hospital discharge ]
    A composite outcome of Death or readmission within the first 30 days of hospital discharge.


Other Outcome Measures:
  1. 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).


  2. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544815


Contacts
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Contact: Nouira Semir, Professor 73106000 ext 00216 semir.nouira@rns.tn
Contact: Bzeouich Nasri, MD 52919170 ext 00216 medecinasri@gmail.com

Locations
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Tunisia
Sahloul University Hospital Recruiting
Hammam sousse, Sousse, Tunisia, 4011
Contact: Boukef Riadh, Professor    73460678 ext 00216    riadh.boukef@rnu.tn   
Fattouma Bourguiba University Hospital Recruiting
Monastir, Tunisia, 5000
Contact: Nouira Semir, Professor    73641144 ext 00216    semir.nouira@rnu.tn   
Contact: nasri Bzeouich, MD    52919170 ext 00216    medecinasri@gmail.com   
Principal Investigator: Nouira Semir, Professor         
Sub-Investigator: Beltaief Kaouthar, MD         
Sub-Investigator: Bzeouich Nasri, MD         
Sponsors and Collaborators
University of Monastir
Investigators
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Principal Investigator: Nouira Semir, Professor University Hospital of Monastir

Publications:
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Responsible Party: Pr. Semir Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02544815    
Other Study ID Numbers: Digoxin - START - AHF
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pr. Semir Nouira, University of Monastir:
digoxin, eficacy, safety
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs