Heart Transplant Patients
Conditions
Keywords
anti-rejection, GI side effects, heart transplant patients
Brief 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).
Interventions
DRUGMyfortic
enteric coated Cellcept pills in applicable dose for patient
Sponsors
Novartis
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in GSRS score | 6 months |
Countries
Canada
Contacts
Primary ContactDr Nadia S Giannetti
Outcome results
None listed