Clinical trial NCT00695344: Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant
Official title: Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiac Transplant
Keywords: Effect of everolimus in graft vascular cardiac illness
Lead sponsor: Fundacion Investigacion y Desarrollo
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility 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.

Primary outcomes:
measure: Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
timeFrame: December 2010
Secondary outcomes:
measure: Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.
timeFrame: December 2010
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
affiliation: Hospital Puerta de Hierro
name: Javier Segovia, cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Nicolás Manito, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria de Navarra
name: Gregorio Rábago, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Francisco González-Vílchez, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Juan Delgado, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañón Hospital
name: Juan Fernández Yañez, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Sonia Mirabet, Cardiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Eulalia Roig, Cardiologist
role: PRINCIPAL_INVESTIGATOR
References: