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Heart FailurePhase 4DECISIONNCT03783429

Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

A Phase 4 study testing Digoxin in people with Heart Failure, run by University Medical Center Groningen at 44 sites in Netherlands.

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

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
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
982 participants
Where
44 sitesNetherlands
Study dates
1 Jul 2020to 13 Nov 2025
Phase
Phase 4
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

  • Age ≥18year
  • Outpatients with chronic HF, New York Heart Association [NYHA] class II - ambulatory IV
  • LVEF<50%
  • Serum NT-proBNP concentrations:
  • Previous HF hospitalization ≤ 1 year before randomisation ≥400pg/mL if sinus rhythm; ≥800pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in the absence of HF hospitalizations ≥ 600pg/mL if sinus rhythm; ≥1000 pg/mL if AF
  • BNP concentrations:
  • Previous HF hospitalization ≤ 1 year before randomisation ≥100pg/mL if sinus rhythm; ≥200pg/mL if AF Previous HF hospitalization > 1 year before randomisation or in absence of HF hospitalization ≥150pg/mL if sinus rhythm; ≥250pg/mL if AF.
  • ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)

Who cannot join

  • Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF)
  • History of HF hospitalization ≤7days
  • History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days
  • Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2
  • The presence of a mechanical assist device
  • Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
Show all 18Show fewer
  • Scheduled for mechanical assist device or heart transplant
  • Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
  • Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
  • Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome)
  • (Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD
  • Severe (grade III/III) aortic valve disease
  • Complex congenital heart disease
  • Proven hypersensitivity to digoxin (prior side effects)
  • Concomitant medication that interacts with digoxin
  • Use of digoxin ≤6 months prior to inclusion
  • Participation in another (intervention) clinical trial (registry studies not included)
  • Women who are pregnant, breastfeeding or may be considering pregnancy during the study period

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

Netherlands44 sites

  • Noordwest Ziekenhuisgroep

    Alkmaar

  • Zorggroep Twente

    Almelo

  • Meander Medisch Centrum

    Amersfoort

  • BovenIJ Ziekenhuis

    Amsterdam

  • Gelre Ziekenhuizen

    Apeldoorn

  • Rijnstate Ziekenhuis

    Arnhem

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Tergooi

    Blaricum

  • Amphia Ziekenhuis

    Breda

  • Ijsselland Ziekenhuis

    Capelle aan den IJssel

  • Reinier de Graaf Gasthuis

    Delft

  • Deventer Ziekenhuis

    Deventer

  • Van Weel Bethesda

    Dirksland

  • Slingeland Ziekenhuis

    Doetinchem

  • Ziekenhuis Gelderse Vallei

    Ede

  • Scheper Ziekenhuis

    Emmen

  • Admiraal de Ruyter Ziekenhuis

    Goes

  • Beatrix Ziekenhuis

    Gorinchem

  • Groene Hart Ziekenhuis

    Gouda

  • Martini Ziekenhuis

    Groningen

  • University Medical Center Groningen

    Groningen

  • Spaarne Gasthuis

    Haarlem

  • Saxenburgh MC

    Hardenberg

  • Ziekenhuis St Jansdal

    Harderwijk

  • Zuyderland Medisch Centrum

    Heerlen

  • Elkerliek Ziekenhuis

    Helmond

  • Bethesda

    Hoogeveen

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Alrijne Ziekenhuis

    Leiden

  • Maastricht UMC+

    Maastricht

  • Isala Diaconessenhuis

    Meppel

  • Radboud University Medical Center

    Nijmegen

  • Bravis ziekenhuis

    Roosendaal

  • Erasmus Medisch Centrum

    Rotterdam

  • Franciscus Gasthuis

    Rotterdam

  • Ikazia Ziekenhuis

    Rotterdam

  • Franciscus Vlietland

    Schiedam

  • Antonius Ziekenhuis Sneek

    Sneek

  • Refaja

    Stadskanaal

  • Haaglanden Medisch Centrum

    The Hague

  • Elisabeth-Tweesteden Ziekenhuis

    Tilburg

  • Diak. Utrecht

    Utrecht

  • Máxima Medisch Centrum

    Veldhoven

  • Zaans Medisch Centrum

    Zaandam

Other trials in Netherlands

About this study

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To confirm these retrospective analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF patients with reduced or mid-range ejection fractions (LVEF <50%).

Conditions
Heart Failure
Being tested
Digoxin, Placebos
Keywords
Heart Failure, Digoxin, Atrial fibrillation
Medical subject headings
Heart Failure, Atrial Fibrillation

What participants receive

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

  • DigoxinDrug

    Digoxin tablets will be given orally

  • PlacebosDrug

    Placebo tablets will be given orally

Study groups in NCT03783429
Study groupRoleWhat they receive
Intervention groupActive comparatorThe intervention group will receive low-dose digoxin
Receives: Drug: Digoxin
Placebo groupPlacebo comparatorThe placebo group will receive a matching placebo
Receives: Drug: Placebos

What is being measured

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

  1. To demonstrate whether low-dose digoxin compared to placebo reduces the rate of the composite CV outcome

    The composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes (amount of events)

    Measured: Median of 3 years

Secondary outcomes (7)

  1. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: composite of all repeated HF hospitalizations and repeated urgent HF visits

    composite of all repeated HF hospitalizations and repeated urgent HF visits (amount)

    Measured: Median of 3 years

  2. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: composite of all repeated CV hospitalizations and repeated urgent CV hospital visits

    composite of all repeated CV hospitalizations and repeated urgent CV hospital visits (amount)

    Measured: Median of 3 years

  3. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of CV-mortality, HF hospitalization or urgent HF hospital visit

    first-time occurrence of any of the composite of CV-mortality, HF hospitalization or urgent HF hospital visit

    Measured: Median of 3 years

  4. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of all-cause mortality, HF hospitalization or urgent HF hospital visit

    first-time occurrence of any of the composite of all-cause mortality, HF hospitalization or urgent HF hospital visit

    Measured: Median of 3 years

  5. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of HF hospitalization or urgent HF hospital visit

    first-time occurrence of any of the composite of HF hospitalization or urgent HF hospital visit

    Measured: Median of 3 years

  6. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first time event to CV mortality

    first time event to CV mortality

    Measured: Median of 3 years

  7. To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time event to all-cause mortality

    first-time event to all-cause mortality

    Measured: Median of 3 years

Timeline

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

  1. First posted21 Dec 2018
  2. Study start1 Jul 2020
  3. Primary completion13 Nov 2025
  4. Study completion13 Nov 2025

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A national, multicenter, randomized, double-blind placebo controlled, clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
982 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03783429
Sponsor's protocol ID
DECISION trial
Acronym
DECISION
Status last verified
Apr 2026
First submitted
13 Dec 2018
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van Veldhuisen DJ, Rienstra M, Mosterd A, Alings M, Voors AA, Damman K, van Asselt ADI, Bouvy ML, Schaap J, van der Wall EE, Crijns HJGM, Touw DJ, Hoogslag PAM, van de Swaluw JEC, Schuurman RJ, van der Sluis A, Bondarenko O, Romer TJ, Oosterhof T, Bartels GL, Koudstaal S, Dijkmans PA, Linssen GCM, Aksoy I, Dorman HGR, Schut A, Hemels MEW, Tieleman RG, Lok DJA, Westendorp ICD, Vijver MAT, Voordes GHD, de Vos AH, Maas-Soer EL, Postmus D, Lunter G, Tijssen JGP, van der Meer P. Low-dose digoxin in patients with heart failure with reduced or mildly reduced ejection fraction: a randomized controlled trial. Nat Med. 2026 Jul;32(7):2647-2653. doi: 10.1038/s41591-026-04406-6. Epub 2026 May 10.

    PubMed 42108270

  • van Veldhuisen DJ, Rienstra M, Mosterd A, Alings AM, van Asselt ADJ, Bouvy ML, Tijssen JGP, Schaap J, van der Wall EE, Voors AA, Boorsma EM, Lok DJA, Crijns HJGM, Schut A, Vijver MAT, Voordes GHD, de Vos AH, Maas-Soer EL, Smit NW, Touw DJ, Samuel M, van der Meer P; DECISION Investigators and Committees. Efficacy and safety of low-dose digoxin in patients with heart failure. Rationale and design of the DECISION trial. Eur J Heart Fail. 2024 Oct;26(10):2223-2230. doi: 10.1002/ejhf.3428. Epub 2024 Aug 30.

    PubMed 39212246

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Digoxin in people with Heart Failure, run by University Medical Center Groningen at 44 sites in Netherlands.

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 8 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 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

To demonstrate whether low-dose digoxin compared to placebo reduces the rate of the composite CV outcome (time frame: Median of 3 years). 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 NCT03783429, which also lists 2 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 27 Apr 2026.

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