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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695344
Recruitment Status : Unknown
Verified January 2009 by Fundacion Investigacion y Desarrollo.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2008
Last Update Posted : January 30, 2009
Information provided by:
Fundacion Investigacion y Desarrollo

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.

Condition or disease Intervention/treatment Phase
Cardiac Transplant Drug: everolimus Drug: azathioprine or mycophenolate mofetil Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: 1
Everolimus 2 times per day + cyclosporin low dose +/- steroids
Drug: everolimus
Everolimus 2 times per day, v.o., 2 years treatment.
Other Name: Certican

Active Comparator: 2
Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study).
Drug: azathioprine or mycophenolate mofetil
2 times per day during 2 years
Other Names:
  • Imurel
  • Cellcept

Primary Outcome Measures :
  1. 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. [ Time Frame: December 2010 ]

Secondary Outcome Measures :
  1. Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis. [ Time Frame: December 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695344

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Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital de Bellvitge
Barcelona, Spain, 08907
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Puerta de Hierro
Madrid, Spain, 28035
Hospital 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Fundacion Investigacion y Desarrollo
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Principal Investigator: Javier Segovia, cardiologist Hospital Puerta de Hierro
Principal Investigator: Nicolás Manito, Cardiologist Hospital Universitari de Bellvitge
Principal Investigator: Gregorio Rábago, Cardiologist Clínica Universitaria de Navarra
Principal Investigator: Francisco González-Vílchez, Cardiologist Hospital Marqués de Valdecilla
Principal Investigator: Juan Delgado, Cardiologist Hospital 12 de Octubre
Principal Investigator: Juan Fernández Yañez, Cardiologist Gregorio Marañón Hospital
Principal Investigator: Sonia Mirabet, Cardiologist Hospital Santa Creu i Sant Pau
Principal Investigator: Eulalia Roig, Cardiologist Hospital Clinic of Barcelona

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Responsible Party: Dr. Javier Segovia, Hospital Puerta de Hierro Identifier: NCT00695344    
Other Study ID Numbers: EVEROSTAT
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009
Keywords provided by Fundacion Investigacion y Desarrollo:
Effect of everolimus in graft vascular cardiac illness
Additional relevant MeSH terms:
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Disease Progression
Disease Attributes
Pathologic Processes
Mycophenolic Acid
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antirheumatic Agents