Status:
UNKNOWN
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Disphar International B.V.
Teva Nederland BV
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
982 Patients enrolled
Trial Details
Trial ID
NCT03783429
Start Date
July 1 2020
End Date
July 1 2025
Last Update
December 12 2023
Active Locations (44)
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1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
2
Zorggroep Twente
Almelo, Netherlands
3
Meander Medisch Centrum
Amersfoort, Netherlands
4
BovenIJ Ziekenhuis
Amsterdam, Netherlands