Evaluating digoxin treatment in patients with rheumatic heart disease - A randomised placebo-controlled trial
Digoxin is widely used in the medical management of patients with rheumatic heart disease (RHD), atrial fibrillation (AF), and for the treatment of heart failure (HF). Observational data from older patients with non-valvular AF suggest a higher mortality risk among those who received digoxin. However, patients with RHD are younger, without associated comorbidity, and it is unclear if digoxin will have similar adverse effects in these patients.
Extrapolating the results of studies in patients without valve disease, to patients with RHD may result in the underuse of an inexpensive treatment which has proven benefit in reducing hospitalisation for worsening HF. Therefore, there is a clear need for an adequately powered randomized controlled trial to answer:
- How does digoxin use affect mortality in patients with RHD?
- Does digoxin use reduce the incidence of worsening heart failure in patients with RHD?
To determine whether the use of digoxin in symptomatic patients with RHD affects mortality, the incidence of new-onset or worsening heart failure, or quality of life (QoL).
There are no extensive randomised controlled studies which have evaluated the efficacy and safety of digoxin in this population. It is an inexpensive drug which may potentially confer significant reductions in HF events in such patients.
This will be the first randomized trial of digoxin in RHD, and the results will provide evidence of the relative benefits of using digoxin in patients with RHD, particularly among those with heart failure or atrial fibrillation.
This is a randomised placebo-controlled superiority 1:1 parallel-group trial conducted over at least 10 tertiary care public hospitals to recruit 1800 participants over a period of 18 months. The study will record data on vital status, hospitalisations, new onset or worsening HF and quality of life scores at pre-designated visits for an average of 24 months after randomisation.
The George Institute, India is a scientific collaborator for this trial and will be providing data management and statistical analysis support.
Trial recruitment was initiated in Feb 2022.