Immunosuppression, Intimal Proliferation
Conditions
Keywords
intima, thickness, transplantation, cardiology, immunosuppression
Brief summary
Randomized prospective multi-center imaging study which investigates the impact of different immunosuppressive protocols (Everolimus (Certican®) or Mycophenolate mofetil (CellCept®)) on cardiac allograft vasculopathy (CAV) in heart transplanted patients. Maximal intima-thickness will be visualized by optical coherence tomography (OCT) to assess the progression of CAV.
Detailed description
In summary, the aim of the study is to examine the effect of the immunosuppressive agent Everolimus (Certican) on the development of cardiac allograft vasculopathy (CAV). Therefore the study is divided in three sections: Substudy 1: Evaluation of morphological differences between between CAD and CAV. Substudy 2: Analysis of cardiovascular risk factors (e.g. hypertension) under a specific immunosuppressive protocol in patients with CAV. Substudy 3: Prospective, randomized analysis of the influence of different immunosuppressive protocols in patients with CAV. Primary endpoint of the study will be the adaption of intimal thickness after 10 years, analysed by means of optical coherence tomography. In addition to the explanations above the most important in- and exclusion criteria are listed below: Inclusion Criteria: * Patients after heart transplantation * Patients with coronary artery disease (CAD) * Age 18-80 years Exclusion Criteria: * Contraindication of Everolimus/Sirolimus or adjuvants * Renal insufficiency (Creatinine \> 265 µmol/l) * Cardiogenic shock or patients with Killip\*-Class III or IV (\*name) * Pregnant or breast feeding females * insufficient contraception (only for substudy 3)
Interventions
OTHERProtocol with Everolimus (Certican®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
OTHERProtocol with Mycophenolate mofetil (CellCept®)
Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
Sponsors
Novartis Pharmaceuticals
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with heart transplantation * Patient with coronary artery disease * Age between 18 and 80 years
Exclusion criteria
* Renal insufficiency (\> 265 µmol/l) * Incapability to give informed consent * Cardiogenic shock of patient with KILLIP III or IV * pregnant or breast feeding females * insufficient contraception (only for substudy 3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intimal Thickness | Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV | Assessment is usually performed by intracoronary angiography and endomyocardial biopsy which is routinely performed \<1 year after heart transplantation. Furthermore, assessment interval will be defined according to the result of these investigational procedures. If there is a diagnosis of CAV the interval will be one year, if not a follow-up examination in two years will be sufficient. |
Countries
Switzerland
Contacts
Primary ContactChristian Templin, MD, PhD
Backup ContactFrank Ruschitzka, Professor
Outcome results
None listed