The DIG-Mod HF trial is an ongoing randomized crossover study designed to evaluate the effect of digoxin 0.125mg daily on peak oxygen consumption and global work index in patients with HFrEF.
RCT (n=50)
Open-label
crossover
Does digoxin 0.125mg daily added to standard of care improve peak oxygen consumption and global work index in adults with chronic HFrEF (LVEF ≤ 45%)?
This paper describes the rationale and design of a trial evaluating the effect of digoxin on functional capacity and cardiac function when added to modern heart failure therapy in patients with HFrEF.
AIMS: Even though it is the oldest heart failure (HF) medication still in use, digoxin has not been evaluated alongside the updated algorithm for treating HF with reduced ejection fraction patients. This could help explain the low use of digoxin in recent HF studies. The main objective is to assess the effectiveness of digoxin in functional capacity and cardiac function when combined with modern HF therapy. METHODS: An interventional, open-label, randomised, crossover trial among adults with chronic Heart Failure and reduced ejection fraction (≤ 45%) was designed to allocate 50 patients for 24 weeks in each arm (48 weeks of study). The arms are daily intake of digoxin 0.125mg plus standard of care versus standard of care alone. Both patients with sinus rhythm and atrial fibrillation were enrolled. At the end of each 24-week arm, patients will undergo the co-primary outcome measurement of the peak oxygen consumption, evaluated through cardiopulmonary exercise test, and the global work index, measured by transthoracic echocardiography. Key secondary outcome includes a safety composite of death, need for urgent heart transplantation or mechanical assist device, total hospitalizations and sustained ventricular arrhythmias. The study completed recruitment in April 2025 and will complete follow up in March 2026. CONCLUSIONS: The use of digoxin could be significantly affected by evidence that it still has a considerable effect on functional capacity and cardiac function in HF patients. EU CT Number: 2024-513448-26-00.
Gonçalves et al. (Fri,) conducted a rct in chronic Heart Failure and reduced ejection fraction (n=50). digoxin vs. standard of care alone was evaluated on peak oxygen consumption and global work index. The DIG-Mod HF trial is an ongoing randomized crossover study designed to evaluate the effect of digoxin 0.125mg daily on peak oxygen consumption and global work index in patients with HFrEF.