NCT00695344

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

Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Fundacion Investigacion y Desarrollo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date. The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months. The two treatment groups are: Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids. Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).

Conditions

• Cardiac Transplant

Interventions

Type	Name	Description
DRUG	everolimus	Everolimus 2 times per day, v.o., 2 years treatment.
DRUG	azathioprine or mycophenolate mofetil	2 times per day during 2 years

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-06-11
• Last updated: 2009-01-30

Locations

8 sites across 1 country: Spain