6/28/23, 1:16 AM DIG Pathway Feedback Search Clinical Topics Home Studies DIG DIG Disease Heart failure Trial question What is the role of digoxin in patients with a LVEF 0.45 being treated with diuretics and ACE inhibitors? Study design Multi-center Double blinded RCT Population Characteristics of study participants 22.0% female N = 6800 78.0% male 6800 patients (1520 female, 5280 male) Inclusion criteria: patients with an LVEF 0.45 being treated with diuretics and ACE inhibitors Key exclusion criteria: age < 21 years, myocardial infarction or cardiac surgery within 4 weeks, unstable or refractory angina < 1 month, acute myocarditis, hypertrophic cardiomyopathy, cor pulmonale, or complex congenital heart disease Interventions N=3397 digoxin (0.25 mg/day) N=3403 placebo (matching placebo per day) Primary outcome https://web.pathway.md/studies/recthrjzIBRHXPKKG 1/2 6/28/23, 1:16 AM DIG Pathway Death from all causes 35.1 % 35.1 34.8 26.3 % 17.6 % 8.8 % No significant difference 0.0 % Digoxin Placebo No significant difference in death from all causes (34.8% vs. 35.1%; RR 0.99, 99% CI 0.91 to 1.07) Secondary outcomes Significant decrease in hospitalization for worsening HF (26.8% vs. 34.7%; RR 0.72, 95% CI 0.66 to 0.79) No significant difference in death attributed to worsening HF (11.6% vs. 13.2%; RR 0.88, 95% CI 0.77 to 1.01) No significant difference in death from cardiovascular causes (29.9% vs. 29.5%; RR 1.01, 95% CI 0.93 to 1.1) Safety outcomes No significant difference in VF or tachycardia. Significant differences in digoxin toxicity (11.9% vs. 7.9%), supraventricular arrhythmia (2.5% vs. 1.2%) and second or third degree AV block (1.2% vs. 0.4%). Conclusion In patients with an LVEF 0.45 being treated with diuretics and ACE inhibitors, digoxin was not superior to placebo with respect to death from all causes. Reference Digitalis Investigation Group. The effect of digoxin on mortality and morbidity in patients with heart failure. N Engl J Med. 1997 Feb 20;336(8):525-33. Open reference URL https://web.pathway.md/studies/recthrjzIBRHXPKKG 2/2