NCT03783429

Digoxin Evaluation in Chronic Heart Failure: Investigational Study In Outpatients in the Netherlands

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 982 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Digoxin	Digoxin tablets will be given orally
DRUG	Placebos	Placebo tablets will be given orally

Timeline

• Start date: 2020-07-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2018-12-21
• Last updated: 2023-12-12

Locations

44 sites across 1 country: Netherlands