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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Fundacion Investigacion y Desarrollo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fundacion Investigacion y Desarrollo
ClinicalTrials.gov Identifier:
NCT00695344
First received: June 9, 2008
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Cardiac Transplant
Drug: everolimus
Drug: azathioprine or mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Fundacion Investigacion y Desarrollo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Enrollment: 52
Study Start Date: January 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695344

Locations
Spain
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de Bellvitge
Barcelona, Spain, 08907
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital Puerta de Hierro
Madrid, Spain, 28035
Sponsors and Collaborators
Fundacion Investigacion y Desarrollo
Investigators
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 Hospital Gregorio Marañón
Principal Investigator: Sonia Mirabet, Cardiologist Hospital Santa Creu i Sant Pau
Principal Investigator: Eulalia Roig, Cardiologist Hospital Clinic de Barcelona
  More Information

No publications provided

Responsible Party: Dr. Javier Segovia, Hospital Puerta de Hierro
ClinicalTrials.gov Identifier: NCT00695344     History of Changes
Other Study ID Numbers: EVEROSTAT
Study First Received: June 9, 2008
Last Updated: January 29, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundacion Investigacion y Desarrollo:
Effect of everolimus in graft vascular cardiac illness

Additional relevant MeSH terms:
Azathioprine
Mycophenolate mofetil
Everolimus
Sirolimus
Mycophenolic Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014