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

NCT06197763 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-17

No results posted yet for this study

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.

Conditions

  • Fontan Circulation

Interventions

DRUG

Colesevelam

625 mg tablets - 3 tables twice per day of Colesevelam or placebo for 6 weeks (crossover), interspersed by 8 week of washout time.

OTHER

Control Arm

No Treatment: baseline assessment only

Sponsors & Collaborators

  • St. Boniface Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-11-01
Completion
2026-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197763 on ClinicalTrials.gov