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

NCT ID: NCT00695344

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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

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Cardiac Transplant

Keywords

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Effect of everolimus in graft vascular cardiac illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Everolimus 2 times per day + cyclosporin low dose +/- steroids

Group Type EXPERIMENTAL

everolimus

Intervention Type DRUG

Everolimus 2 times per day, v.o., 2 years treatment.

2

Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study).

Group Type ACTIVE_COMPARATOR

azathioprine or mycophenolate mofetil

Intervention Type DRUG

2 times per day during 2 years

Interventions

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everolimus

Everolimus 2 times per day, v.o., 2 years treatment.

Intervention Type DRUG

azathioprine or mycophenolate mofetil

2 times per day during 2 years

Intervention Type DRUG

Other Intervention Names

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Certican Imurel Cellcept

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Investigacion y Desarrollo

OTHER

Sponsor Role lead

Responsible Party

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Hospital Puerta de Hierro

Principal Investigators

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Javier Segovia, cardiologist

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro

Nicolás Manito, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Gregorio Rábago, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria de Navarra

Francisco González-Vílchez, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

Juan Delgado, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Juan Fernández Yañez, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Gregorio Marañón Hospital

Sonia Mirabet, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Eulalia Roig, Cardiologist

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Hospital de Bellvitge

Barcelona, Barcelona, Spain

Site Status

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Gregorio Marañón

Madrid, Madrid, Spain

Site Status

Hospital Puerta de Hierro

Madrid, Madrid, Spain

Site Status

Hospital 12 de Octubre

Madrid, Madrid, Spain

Site Status

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

Other Identifiers

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EVEROSTAT

Identifier Type: -

Identifier Source: org_study_id