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Old heart drug gets a second look: can low doses save lives?

NCT ID NCT03783429

Disease control Sponsor: University Medical Center Groningen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether low doses of digoxin, an old and cheap heart drug, can reduce hospitalizations and death in 982 heart failure patients. Participants received either digoxin or a placebo pill. The goal is to see if keeping digoxin levels low in the blood improves outcomes without the risks seen at higher doses.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Digoxin
What this could lead to
If successful, low-dose digoxin could become a cheap, widely available option to reduce heart failure hospitalizations and possibly improve survival.
What could go wrong
This is a phase 4 trial confirming earlier findings, but digoxin has a narrow safety margin and may still show no mortality benefit, as seen in the original DIG trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

982 people

The number who actually took part.

Started

Jul 2020

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥18year 2. Outpatients with chronic HF, New York Heart Association \[NYHA\] class II - ambulatory IV 3. LVEF\<50% 4. 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. 5. ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient) Exclusion Criteria: 1. Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF) 2. History of HF hospitalization ≤7days 3. History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days 4. Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2 5. The presence of a mechanical assist device 6. Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon) 7. Scheduled for mechanical assist device or heart transplant 8. Other non-cardiac conditions with limited life expectancy (≤ duration of the study) 9. Amyloid, hypertrophic obstructive or constrictive cardiomyopathy 10. Accessory atrio-ventricular pathway (e.g. Wolf-Parkinson-White syndrome) 11. (Intermittent) complete heart block or second-degree AV block type Mobitz without pace maker or ICD 12. Severe (grade III/III) aortic valve disease 13. Complex congenital heart disease 14. Proven hypersensitivity to digoxin (prior side effects) 15. Concomitant medication that interacts with digoxin 16. Use of digoxin ≤6 months prior to inclusion 17. Participation in another (intervention) clinical trial (registry studies not included) 18. Women who are pregnant, breastfeeding or may be considering pregnancy during the study period

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Conditions

The condition(s) this trial relates to.

atrial fibrillation heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Admiraal de Ruyter Ziekenhuis

    Goes, Netherlands

  • Alrijne Ziekenhuis

    Leiden, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Antonius Ziekenhuis Sneek

    Sneek, Netherlands

  • Beatrix Ziekenhuis

    Gorinchem, Netherlands

  • Bethesda

    Hoogeveen, Netherlands

  • BovenIJ Ziekenhuis

    Amsterdam, Netherlands

  • Bravis ziekenhuis

    Roosendaal, Netherlands

  • Deventer Ziekenhuis

    Deventer, Netherlands

  • Diak. Utrecht

    Utrecht, Netherlands

  • Elisabeth-Tweesteden Ziekenhuis

    Tilburg, Netherlands

  • Elkerliek Ziekenhuis

    Helmond, Netherlands

  • Erasmus Medisch Centrum

    Rotterdam, Netherlands

  • Franciscus Gasthuis

    Rotterdam, Netherlands

  • Franciscus Vlietland

    Schiedam, Netherlands

  • Gelre Ziekenhuizen

    Apeldoorn, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • Haaglanden Medisch Centrum

    The Hague, Netherlands

  • Ijsselland Ziekenhuis

    Capelle aan den IJssel, Netherlands

  • Ikazia Ziekenhuis

    Rotterdam, Netherlands

  • Isala Diaconessenhuis

    Meppel, Netherlands

  • Maastricht UMC+

    Maastricht, Netherlands

  • Martini Ziekenhuis

    Groningen, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • Máxima Medisch Centrum

    Veldhoven, Netherlands

  • Noordwest Ziekenhuisgroep

    Alkmaar, Netherlands

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • Refaja

    Stadskanaal, Netherlands

  • Reinier de Graaf Gasthuis

    Delft, Netherlands

  • Rijnstate Ziekenhuis

    Arnhem, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, Netherlands

  • Saxenburgh MC

    Hardenberg, Netherlands

  • Scheper Ziekenhuis

    Emmen, Netherlands

  • Slingeland Ziekenhuis

    Doetinchem, Netherlands

  • Spaarne Gasthuis

    Haarlem, Netherlands

  • Tergooi

    Blaricum, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

  • Van Weel Bethesda

    Dirksland, Netherlands

  • Zaans Medisch Centrum

    Zaandam, Netherlands

  • Ziekenhuis Gelderse Vallei

    Ede, Netherlands

  • Ziekenhuis St Jansdal

    Harderwijk, Netherlands

  • Zorggroep Twente

    Almelo, Netherlands

  • Zuyderland Medisch Centrum

    Heerlen, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.