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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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: >=400pg/mL if sinus rhythm; >=800pg/mL
if AF
- Previous HF hospitalization > 1 year or in the absence of HF hospitalization:
>=600pg/mL if sinus rhythm; >=1000pg/mL if AF
5. >=14 days stable on guideline-recommended therapy (doses and number of
therapies as tolerated by each patient)

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the composite of (repeated) HF hospitalizations,<br /><br>(repeated) urgent HF hospital visits and cardiovascular death.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. All-cause mortality<br />2. Cardiovascular death<br />3. (Repeated) HF hospitalization<br />4. (repeated) urgent HF hospital visits<br />5. Cost-effectiveness.<br />6. All-cause hospitalizations<br />7. Unscheduled cardiovascular hospital visits<br />8. Days alive out of hospital<br />9. Quality of Life<br />10. Heart rate in both AF and sinus rhythm<br />11. To assess side effects (including SUSARs) associated with study medication<br />12. Initiation of (recurrence of) AF in patients with sinus rhythm at baseline<br />13. Conversion to sinus rhythm and maintenance of sinus rhythm in patients with<br />AF at baseline.<br />14. Proteomics and validating hits in elisa*s. </p>