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Acute Heart FailurePhase 3DIG-STA-AHFNCT02544815

Digoxin Short Term Treatment Assessment Randomized Trial in AHF

A Phase 3 study testing Digoxin in people with Acute Heart Failure, run by University of Monastir at 2 sites in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
Digoxin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
2 sitesTunisia
Study dates
1 May 2023to 31 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnant or breast feeding women.
  • Known severe or terminal renal failure.
  • Severe hepatic impairment.
  • Major surgery within 30 days.
  • Hematocrit < 25%.
  • Alteration of consciousness GCS < 15
Show all 18Show fewer
  • 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 before inclusion or contra-indications to digoxin.
  • Inability to follow instructions or comply with follow-up procedures.

Trial locations and contacts

2 sites in 1 country.

Tunisia2 sites

  • Sahloul University Hospital

    Hammam Sousse, Sousse Governorate, 4011

  • Fattouma Bourguiba University Hospital

    Monastir, 5000

Other trials in Tunisia

About this study

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.

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.

Read the 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.

Being tested
Digoxin, Placebo
Keywords
digoxin, eficacy, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigoxinDrug

    Digoxin 0.25 mg pills

  • PlaceboDrug

    Placebo pills

Study groups in NCT02544815
Study groupRoleWhat they receive
DigoxinActive comparatorOral digoxin 0.25 mg: one pill per day for 30 consecutive days.
Receives: Drug: Digoxin
PlaceboPlacebo comparatorOral placebo for 30 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30 days mortality and rehospitalization rate

    Measured: 30 days

Secondary outcomes (8)

  1. 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.

    Measured: 3 days

  2. Need for hospitalization

    Measured: 3 days

  3. Length of stay in hospital

    Measured: from baseline to hospital discharge

  4. 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.

    Measured: 3 days

  5. 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.

    Measured: [Time Frame: 6, 12, and 24 hours from start of the study medication]

  6. 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.

    Measured: 3 days

  7. 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).

    Measured: 30 days

  8. Worsening renal function

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2015 (estimated)
  2. Study start1 May 2023
  3. Primary completion31 Aug 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02544815
Sponsor's protocol ID
Digoxin - START - AHF
Acronym
DIG-STA-AHF
Status last verified
Oct 2026
First submitted
5 Sep 2015
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16365214

  • 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.

    PubMed 9036306

  • 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.

    PubMed 24067296

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Digoxin in people with Acute Heart Failure, run by University of Monastir at 2 sites in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30 days mortality and rehospitalization rate (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02544815, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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