Heart failure
Conditions
Interventions
Trade Name: DIGOXIN TEVA, 100 µg, tablets
Product Name: DIGOXIN TEVA, 100 µg, tablets
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: O
Sponsors
Department of Cardiology, Hartcentrum, University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations and cardiovascular mortality, compared to placebo, in chronic HF.;Secondary Objective: -To assess whether low-level digoxin reduces all-cause mortality -To assess whether low-level digoxin reduces cardiovascular death -To assess whether low-level digoxin reduces (repeated) HF hospitalizations -To assess whether low-level digoxin treatment is cost-effective -To assess whether low-level digoxin reduces all-cause hospitalizations -To assess whether low-level digoxin reduces unscheduled cardiovascular hospital visits -To assess whether low-level digoxin reduces days alive out of hospital of patients -To assess whether low-level digoxin improves QoL -To assess side effects (including SUSARs) associated with study medication -To study the effect of low-level digoxin on heart rate in both AF and sinus rhythm -To assess whether low-level digoxin reduces initiation of (recurrence of) AF in patients with sinus rhythm at baseline -To assess whether low-level digoxin increases conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline;Primary end point(s): The composite of repeated HF hospitalizations and cardiovascular death.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. All-cause mortality 2. Cardiovascular death 3. (Repeated) HF hospitalization 4. Cost-effectiveness. 5. All-cause hospitalizations 6. Unscheduled cardiovascular hospital visits 7. Days alive out of hospital 8. Quality of Life 9. Heart rate in both AF and sinus rhythm 10. To assess side effects (including SUSARs) associated with study medication 11. Initiation of (recurrence of) AF in patients with sinus rhythm at baseline 12. Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline.;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated at the end of the study | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials Information
Department of Cardiology, Thoraxcenter, University Medical Center Groningen
Outcome results
None listed