DECISION; Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands
Key facts
- Where
- Groningen, HollandiaSee the site
- Phase
- 4. fázis
Where in Hollandia
- Universitair Medisch Centrum GroningenGroningen, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Medisch Centrum Groningen
- Trial code
- EU 2023-509898-23-00
- Record updated
- 2026. január 12.
- Original description
To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular mortality, compared to placebo, in chronic HF.Read full original descriptionShow less
To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular mortality, compared to placebo, in chronic HF.
Inclusion: Age ≥18year; Outpatients with chronic HF, NYHA II - ambulatory IV; LVEF ≤50%; Serum NT-proBNP concentrations (max 1 month old): 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 (max 1 month old): 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).
Exclusion: Proven hypersensitivity to digoxin (prior side effects); Concomitant medication that interacts with digoxin (see appendix 2, prohibited medication); Use of digoxin ≤6 months prior to inclusion; Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon); Heart rate ≤60bpm (if sinus rhythm); heart rate ≤70bpm (if AF); 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; History of HF hospitalization ≤7days; History of myocardial infarction, myocarditis, percutaneous intervention, RCT, pacemaker/ICD implantation, cardiac surgery or stroke ≤30 days; Scheduled for mechanical assist device or heart transplant; Other non-cardiac conditions with limited life expectancy (≤ duration of the study); Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2 (max 1 month old); Participation in another (intervention) clinical trial (registry studies not included); Women who are pregnant, breastfeeding or may be considering pregnancy during the study period; The presence of a mechanical assist device; Amyloid, hypertrophic obstructive or constrictive cardiomyopathy.