Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands (DECISION)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Digoxin, Atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Noordwest Ziekenhuisgroep
- Zorggroep TwenteRecruiting
- Meander Medisch CentrumRecruiting
- BovenIJ ZiekenhuisRecruiting
- Onze Lieve Vrouwe Gasthuis
- Gelre ZiekenhuizenRecruiting
- Rijnstate ZiekenhuisRecruiting
- Rode Kruis ZiekenhuisRecruiting
- TergooiRecruiting
- Amphia ZiekenhuisRecruiting
- Ijsselland ZiekenhuisRecruiting
- Reinier de Graaf GasthuisRecruiting
- Haaglanden Medisch CentrumRecruiting
- Deventer ZiekenhuisRecruiting
- Van Weel Bethesda
- Slingeland Ziekenhuis
- Ziekenhuis Gelderse Vallei
- Scheper ZiekenhuisRecruiting
- Admiraal de Ruyter ZiekenhuisRecruiting
- Beatrix Ziekenhuis
- Groene Hart ZiekenhuisRecruiting
- Martini ZiekenhuisRecruiting
- University Medical Center GroningenRecruiting
- Spaarne GasthuisRecruiting
- Saxenburgh MCRecruiting
- Ziekenhuis St Jansdal
- Zuyderland Medisch CentrumRecruiting
- Elkerliek ZiekenhuisRecruiting
- BethesdaRecruiting
- Medisch Centrum LeeuwardenRecruiting
- Alrijne ZiekenhuisRecruiting
- Maastricht UMC+
- Isala DiaconessenhuisRecruiting
- Radboud University Medical CenterRecruiting
- Bravis ziekenhuisRecruiting
- Erasmus Medisch CentrumRecruiting
- Franciscus GasthuisRecruiting
- Ikazia ZiekenhuisRecruiting
- Franciscus VlietlandRecruiting
- Antonius Ziekenhuis SneekRecruiting
- RefajaRecruiting
- Elisabeth-Tweesteden ZiekenhuisRecruiting
- Diak. UtrechtRecruiting
- Máxima Medisch CentrumRecruiting
- Zaans Medisch CentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Intervention group
Placebo group
The intervention group will receive low-dose digoxin
The placebo group will receive a matching placebo