Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands (NCT03783429) | Clinical Trial Compass
CompletedPhase 4
Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Netherlands982 participantsStarted 2020-07-01
Plain-language 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 in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To confirm these retrospective analyses, a prospective, randomized, placebo-controlled trial is necessary to establish the position of digoxin in the contemporary treatment of HF. Therefore, the investigators examine whether low-level, aiming for serum concentrations 0.5-0.9ng/mL, digoxin is beneficial in HF patients with reduced or mid-range ejection fractions (LVEF \<50%).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18year
✓. Outpatients with chronic HF, New York Heart Association \[NYHA\] class II - ambulatory IV
✓. LVEF\<50%
✓. Serum NT-proBNP concentrations:
✓. ≥14 days stable on guideline-recommended therapy (doses and number of therapies as tolerated by each patient)