Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands
Status:
Recruiting
Trial end date:
2025-07-01
Target enrollment:
Participant gender:
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%).
Phase:
Phase 4
Details
Lead Sponsor:
University Medical Center Groningen
Collaborators:
Disphar International B.V. Netherlands Heart Foundation Teva Nederland BV Tiofarma BV WCN (Werkgroep Cardiologische centra Nederland) ZonMw: The Netherlands Organisation for Health Research and Development