Heart failure & cardiomyopathiesTrial design
MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention
- 2-center, pragmatic, open-label randomized controlled trial
- stratified by sex, age (<65 versus ≥65 years), and left ventricular ejection fraction (<50% versus ≥50%)
- 1:1 randomization
- data analysts blinded to group assignment until study completion
- community-based-participatory methods
- rationale and design
Study context
- Population
- Diné patients with heart failure and hospitalization, or emergency room visit in the last 12 months, at 2 Indian Health Service sitesplanned subjects to be randomized
- Participants
- Two hundred and four patients
- Planned comparison
- culturally and medically tailored meals that incorporate traditional Diné recipes and foods or usual dietary advice for 8 weeks
- Primary endpoint
- Proportion of patients with a hospitalization or emergency room visit (all-cause)
- Follow-up
- Within 90 days
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention. Circ Heart Fail. Published 2 March 2026. doi:10.1161/circheartfailure.125.014013
Summarised from the published abstract; every number is checked against it