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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus (Certican®) | Experimental | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). No protocol with Mycophenolate mofetil (CellCept®). Daily dosage administered depending on blood concentration (control interval 6-12 months) |
|
| Mycophenolate mofetil (CellCept®) | Active Comparator | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). No protocol with Everolimus (Certican®). Daily dosage administered depending on blood concentration (control interval 6-12 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol with Everolimus (Certican®) | Other | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intimal Thickness | 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. | Assessment intervals of patients with CAV is 1 year and 2 years in patients without CAV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Templin, MD, PhD | Contact | +41 (0)44 / 255 9585 | christian.templin@usz.ch | |
| Frank Ruschitzka, Professor | Contact | +41 (0)44 / 255 3957 | frank.ruschitzka@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christian Templin, MD, PhD | University Hospital Zurich (Switzerland), Division of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Cardiology | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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| Label | URL |
|---|---|
| Informations about Optical Coherence Tomography (OCT) | View source |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Protocol with Mycophenolate mofetil (CellCept®) | Other | Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®). |
|
|
| D017530 | Health Care Quality, Access, and Evaluation |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |