Clinical Research Directory

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