Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197763
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-10-04
Brief Title:
Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation
Sponsor:
St Boniface Hospital
Organization:
St Boniface Hospital
Study Overview
Official Title:
Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation MYSTIC Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYSTIC
Brief Summary:
This is the first pilot study proposing a novel therapeutic option treating patients with Fontan circulation FC a high-risk condition that has no definite treatment options available other than heart or heart-liver transplantation The investigators identification of elevated BA and their association with adverse clinical - investigational features in Fontan patients are novel
Detailed Description:
The investigators propose a prospective double-blind placebo cross-over pilot study evaluating colesevelam intestinal BA scavenger therapy and placebo in 25 stable adult FC participants These participants will be recruited from the cardiology clinics at the St Boniface Hospital specifically the Manitoba Adult Congenital Heart MACH Clinic Participants will be randomized to be treated with either colesevelam 625 mg tablets - 3 tables twice per day or placebo 3 tablets twice per day for 6 weeks interspersed by 8 week of washout time Local research and ethics board approval will be obtained Informed consent will be obtained from all participants
A further 25 age- and sex- matched healthy control participants will be recruited from advertising at St Boniface Hospital and University of Manitoba These healthy control participants will be comparators to the randomized Fontan participants at baseline Recruitment of this group will be completed after all Fontan participants have been screened consented and randomized to ensure accuracy of age and sex matching Age and sex matched participants will be - 3 years and not pregnant or nursing at time of study visit
A further 25 age- and sex- matched healthy control participants will be recruited from advertising at St Boniface Hospital and University of Manitoba These healthy control participants will be comparators to the randomized Fontan participants at baseline Recruitment of this group will be completed after all Fontan participants have been screened consented and randomized to ensure accuracy of age and sex matching Age and sex matched participants will be - 3 years and not pregnant or nursing at time of study visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None