Spaarne Gasthuis | Haarlem Zuid - Cardiology
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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%).
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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:
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 criteria
Primary purpose
Allocation
Interventional model
Masking
982 participants in 2 patient groups, including a placebo group
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Central trial contact
Michiel Rienstra, MD, PhD
Data sourced from clinicaltrials.gov
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