Valvular & structural heart disease
Digoxin in rheumatic heart disease: Rationale and design of a multicenter, placebo-controlled double-blind randomized controlled trial (Digoxin in RHD (Dig-RHD) trial)
Authors' conclusion
Dig-RHD is the first randomized trial of digoxin in RHD powered for clinical outcomes
Study context
- Population
- Symptomatic adults with rheumatic heart disease, Indiaenrolled Feb 2022–Aug 2024
- Participants
- 1,769 adults
- Comparison
- Oral digoxin vs matching placebo, on usual care
- Primary endpoint
- Composite of:
- All-cause death
- New-onset
- Worsening HF
Methodological detailsinvestigator-initiated, multicentre (12 academic centres, India), pragmatic, placebo-controlled, double-blind, parallel-arm, superiority, Last follow-up visits scheduled to complete December 2025, Key secondary outcomes: all-cause death, heart failure (HF)-related death, HF hospitalisation, sudden death, self-reported quality of life
- Investigator-initiated
- Multicentre (12 academic centres, India)
- Pragmatic
- Placebo-controlled
- Double-blind
- Parallel-arm
- Superiority
- Last follow-up visits scheduled to complete December 2025
- Key secondary outcomes: all-cause death, HF-related death, HF hospitalisation, sudden death, self-reported quality of life
Primary result
As reported in the abstract
- Design paper: no results reported; last follow-up due December 2025
Safety
Safety at DSMB interim review · after half the primary outcome events
- No safety signals
- Interim analysis
Original publication
Digoxin in rheumatic heart disease: Rationale and design of a multicenter, placebo-controlled double-blind randomized controlled trial (Dig-RHD trial). Am Heart J. Published 12 May 2025. doi:10.
Summarised from the published abstract; every number is checked against it