Impact of Therapy Using Colesevelam Treatment Reducing Bile Acids in Patients With Fontan Circulation.

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

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 investigator's identification of elevated BA and their association with adverse clinical - investigational features in Fontan patients are novel.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Boniface Hospital
• Treatments: Colesevelam Hydrochloride

Criteria

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