Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
NCT ID: NCT03783429
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
982 participants
INTERVENTIONAL
2020-07-01
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention group
The intervention group will receive low-dose digoxin
Digoxin
Digoxin tablets will be given orally
Placebo group
The placebo group will receive a matching placebo
Placebos
Placebo tablets will be given orally
Interventions
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Digoxin
Digoxin tablets will be given orally
Placebos
Placebo tablets will be given orally
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Disphar International B.V.
INDUSTRY
Teva Nederland BV
UNKNOWN
Tiofarma BV
UNKNOWN
Netherlands Heart Foundation
OTHER
Werkgroep Cardiologische centra Nederland
UNKNOWN
University Medical Center Groningen
OTHER
Responsible Party
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M. Rienstra
Prof. Dr.
Principal Investigators
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Michiel Rienstra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Peter van der Meer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Dirk J van Veldhuisen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Zorggroep Twente
Almelo, , Netherlands
Meander Medisch Centrum
Amersfoort, , Netherlands
BovenIJ Ziekenhuis
Amsterdam, , Netherlands
Gelre Ziekenhuizen
Apeldoorn, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Rode Kruis Ziekenhuis
Beverwijk, , Netherlands
Tergooi
Blaricum, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Ijsselland Ziekenhuis
Capelle aan den IJssel, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Van Weel Bethesda
Dirksland, , Netherlands
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Ziekenhuis Gelderse Vallei
Ede, , Netherlands
Scheper Ziekenhuis
Emmen, , Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, , Netherlands
Beatrix Ziekenhuis
Gorinchem, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Saxenburgh MC
Hardenberg, , Netherlands
Ziekenhuis St Jansdal
Harderwijk, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Elkerliek Ziekenhuis
Helmond, , Netherlands
Bethesda
Hoogeveen, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Alrijne Ziekenhuis
Leiden, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Isala Diaconessenhuis
Meppel, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Bravis ziekenhuis
Roosendaal, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Franciscus Gasthuis
Rotterdam, , Netherlands
Ikazia Ziekenhuis
Rotterdam, , Netherlands
Franciscus Vlietland
Schiedam, , Netherlands
Antonius Ziekenhuis Sneek
Sneek, , Netherlands
Refaja
Stadskanaal, , Netherlands
Haaglanden Medisch Centrum
The Hague, , Netherlands
Elisabeth-Tweesteden Ziekenhuis
Tilburg, , Netherlands
Diak. Utrecht
Utrecht, , Netherlands
Máxima Medisch Centrum
Veldhoven, , Netherlands
Zaans Medisch Centrum
Zaandam, , Netherlands
Countries
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References
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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.
Other Identifiers
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DECISION trial
Identifier Type: -
Identifier Source: org_study_id