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

NCT00695344 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-01-30

No results posted yet for this study

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.

Conditions

  • Cardiac Transplant

Interventions

DRUG

everolimus

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

DRUG

azathioprine or mycophenolate mofetil

2 times per day during 2 years

Sponsors & Collaborators

  • Fundacion Investigacion y Desarrollo

    lead OTHER

Principal Investigators

  • Javier Segovia, cardiologist · Hospital Puerta de Hierro

  • Nicolás Manito, Cardiologist · Hospital Universitari de Bellvitge

  • Gregorio Rábago, Cardiologist · Clínica Universitaria de Navarra

  • Francisco González-Vílchez, Cardiologist · Hospital Marqués de Valdecilla

  • Juan Delgado, Cardiologist · Hospital 12 de Octubre

  • Juan Fernández Yañez, Cardiologist · Gregorio Marañón Hospital

  • Sonia Mirabet, Cardiologist · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  • Eulalia Roig, Cardiologist · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00695344 on ClinicalTrials.gov