Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 982

Inclusion Criteria

1. Age =18 years
2. Outpatients with chronic HF, NYHA 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 (recent) 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 (recent) HF hospitalization =150pg/mL if sinus rhythm; =250pg/mL if AF.

6. =14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 982
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 982

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 transplantation
8. Other non-cardiac conditions with limited life expectancy
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 pacemaker
12. Severe (grade III/III) aortic valve disease
13. Complex congenital heart disease
14. Proven hypersensitivity to digoxin
15. Concomitant medication that interact with digoxin
16. Use of digoxin =6 months prior to inclusion
17.Participation in another clinical trial (registry studies not included)
18. Women who are pregnant, breastfeeding or may be considering pregnancy during the study period

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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