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

Prior treatment

• Use of inotropic drugs (dopamine, dobutamine, (nor)adrenaline, and milrinon)
• Proven hypersensitivity to digoxin (prior side effects)
• Concomitant medication that interacts with digoxin
• Use of digoxin ≤6 months prior to inclusion

Other illness

• 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
• Scheduled for mechanical assist device or heart transplant
• Other non-cardiac conditions with limited life expectancy (≤ duration of the study)
• 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

Lab values

• Estimated glomerular filtration rate (eGFR), ≤30ml/min/1.73m2

Other

• The presence of a mechanical assist device
• Amyloid, hypertrophic obstructive or constrictive cardiomyopathy
• Participation in another (intervention) clinical trial (registry studies not included)
• Women who are pregnant, breastfeeding or may be considering pregnancy during the study period

• 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)