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

Cardiac Transplant Clinical Trial

— EVEROSTAT  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00695344
• Other study ID #: EVEROSTAT
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 9, 2008
• Last updated: January 29, 2009
• Start date: January 2006
• Est. completion date: June 2010

Study information

• Verified date: January 2009
• Source: Fundacion Investigacion y Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Transplant

Intervention

Drug:
• everolimus
Everolimus 2 times per day, v.o., 2 years treatment.
• azathioprine or mycophenolate mofetil
2 times per day during 2 years

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Investigacion y Desarrollo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		December 2010	Yes
Secondary	Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.		December 2010	Yes