Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

Hannover Medical School23 enrolled

Overview

The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Transplantation

Interventions

MycophenolatmofetileDRUG

Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily

Cyclosporin ADRUG

Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month * Heart transplantation above 3 years dated back * Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl * Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month Exclusion Criteria: * Carcinoma within the last 3 years * Acute rejection episodes during the last 6 month * Infection requiring therapeutic intervention * Hepatitis B, Hepatitis C or HIV infection * WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl * Florid gastrointestinal ulcer * Haemodialysis within the last 4 weeks before study entry * Pregnancy / lactation * Administration of other immunosuppressive agents than prescribed * Mycophenolatmofetile incompatibility

Locations (1)

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Hanover, Germany

Outcomes

Primary Outcomes

Renal function evaluated by serum creatinine at month 12 and month 24

Time frame: month 12 and month 24

Secondary Outcomes

acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24

Time frame: month 12 and month 24

Cardiovascular risk factors at month 12 and month 24

Time frame: month 12 and month 24

Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24

Time frame: month 12 and month 24

Data from ClinicalTrials.gov

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