Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborator: Novartis
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Stable dose MMF for at least 4 weeks

• Over 18 years of age

• Heart transplant at least three months prior to study

Exclusion Criteria:

• GI symptoms known not to be caused by MPA therapy

• Acute rejection episode in past 4 weeks

• History of malignancy since transplant

• Pregnancy