Intracoronary Analysis of Cardiac Allograft Vasculopathy by Means of Optical Coherence Tomography (OCTandCAV)

University of Zurich (UZH)

Status and phase: Unknown; Phase 4

Conditions: Intimal Proliferation; Immunosuppression

Treatments: Other: Protocol with Mycophenolate mofetil (CellCept®); Other: Protocol with Everolimus (Certican®)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02254668

KEK-ZH_Nr. 2012-0409

Details and patient eligibility

About

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.

Full 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)

Enrollment: 278 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

278 participants in 2 patient groups

Everolimus (Certican®)

Experimental group

Description:

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)

Treatment:

Other: Protocol with Everolimus (Certican®)

Mycophenolate mofetil (CellCept®)

Active Comparator group

Description:

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)

Treatment:

Other: Protocol with Mycophenolate mofetil (CellCept®)