Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Investigacion y Desarrollo
• Treatments: Azathioprine; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

• Patients suffering a heart transplantation at least 12 months before the inclusion.

• Patients with significant graft vascular cardiac illness.

Exclusion Criteria:

• Patients who received more than one solid organ.

• Hypersensibility to everolimus.

• Patients with expected surviving less than 6 months.

• Analytic abnormality significant (platelets < 70.000 plat./mm3, WBC<4.000./mm3, creatinine > 2,5 mg/dl)

• Neoplasm and/or severe systemic illness.

• Mental significant illness.

• Patients who have received sirolimus or everolimus in any moment after transplant.

• Pregnant or lactating woman.