Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

McGill University Health Centre/Research Institute of the McGill University Health Centre100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Heart Transplant Patients

Interventions

enteric coated Cellcept pills in applicable dose for patient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

reduction in GSRS score

Time frame: 6 months

Central Contacts

Dr Nadia S Giannetti

CONTACT

(514) 934 1934 nadia.giannetti@muhc.mcgill.ca

Data from ClinicalTrials.gov

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