Status:
NOT_YET_RECRUITING
Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.
Lead Sponsor:
St. Boniface Hospital
Conditions:
Fontan Circulation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 he...
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 pa...
Eligibility Criteria
Inclusion
- Inclusion criteria - Fontan participants
- i) Of full age of consent (at least ≥ 18 years of age) at screening
- ii) Signed and dated written informed consent in accordance with ICF-GCP and local regulations prior to admission to the study
- iii) Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant informed consent form.
- iv) Diagnosis of Fontan circulation documented in the participant's medical record
- Inclusion criteria - Healthy control participants
- i) Of full age of consent (at least ≥ 18 years of age) at screening
- ii) Signed and dated written informed consent in accordance with ICF-GCP and local regulations prior to admission to the study
- iii) Male or female participants
- Exclusion criteria - Fontan participants
- i) Has previously received a heart or heart-liver transplant
- ii) Contraindication for using colesevelam, including allergy
- iii) Any physical or mental condition significantly affecting the participant's ability to participate in the investigator's opinion
- iv) Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Exclusion criteria - Healthy control participants
- i) Any known medical condition
- ii) Any physical or mental condition significantly affecting the participant's ability to participate in the investigator's opinion
- iii) Women who are pregnant or nursing at time of study visit
Exclusion
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06197763
Start Date
June 1 2024
End Date
May 1 2026
Last Update
April 17 2024
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