NCT00695344

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

4.4 years

First QC Date

June 9, 2008

Last Update Submit

January 29, 2009

Conditions

Cardiac Transplant

Keywords

Effect of everolimus in graft vascular cardiac illness

Outcome Measures

Primary Outcomes (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.

    December 2010

Secondary Outcomes (1)

  • Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.

    December 2010

Study Arms (2)

1

EXPERIMENTAL

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

Drug: everolimus

2

ACTIVE COMPARATOR

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

Drug: azathioprine or mycophenolate mofetil

Interventions

everolimusDRUG

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

Also known as: Certican
1
azathioprine or mycophenolate mofetilDRUG

2 times per day during 2 years

Also known as: Imurel, Cellcept
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with significant graft vascular cardiac illness.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Hospital de Bellvitge

Barcelona, Barcelona, 08907, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Puerta de Hierro

Madrid, Madrid, 28035, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Interventions

EverolimusAzathioprineMycophenolic Acid

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsThionucleosidesSulfur CompoundsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • 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

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

    PRINCIPAL INVESTIGATOR

  • Eulalia Roig, Cardiologist

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 30, 2009

Record last verified: 2009-01

Locations

ES(8)