Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-25 @ 3:49 AM
NCT ID:
NCT00505102
Eligibility Criteria:
Inclusion Criteria:
* Heart Transplant patients with more than 1 year of follow-up
* Creatinine lower than 3.5 mg/dl
* GFR Higher than 20 ml/min (calculated with Cockcroft-Gault formula)
* Cyclosporine in maintenance immunosuppressive therapy
* Patient must be able to sign an approve informed consent
* Prior History of acute rejection within the last 3 months
* Females of childbearing age may be included if pregnancy is excluded and acceptable contraception measures are used
Exclusion Criteria:
* Patients who are recipients of multiple organ transplants
* Prior or current use of sirolimus or everolimus
* History of acute rejection within the last 6 months
* Coronary Artery Bypass Surgery or other cardiac surgery in the past 3 months
* Patient not able to attend all follow-up evaluations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00505102
Study Brief:
Protocol Section:
NCT00505102