IMpact of therapY using coleSevelam treatment reducing bile acids in patients with fonTan cIrCulation (MYSTIC): Rationale and study design
Study context
- Population
- Adult Fontan patients, with age- and sex-matched healthy controls for baseline comparisonsEstimated enrollment: 25 patients and 25 healthy subjects, enrollment dates September 2025 to August 2027 · adult Fontan patients 25 · age- and sex-matched healthy controls 25
- Planned comparison
- Colesevelam vs placebo in lowering plasma BA levels
- Healthy controlsn = 25
- Primary endpoint
- Safety/tolerability and change in total plasma BA levels
Methodological detailsSingle center, rationale and design manuscript
- Single center
- Rationale and design manuscript
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
IMpact of therapY using coleSevelam treatment reducing bile acids in patients with fonTan cIrCulation (MYSTIC): Rationale and study design. Am Heart J. Published 19 August 2025. doi:10.
Summarised from the published abstract; every number is checked against it