Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

Hannover Medical School40 enrolled

Overview

The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, 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. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Transplantation

Interventions

prednisolonDRUG

prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal

MycophenolatmofetileDRUG

Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily

Cyclosporin ADRUG

Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 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 and corticosteroids for at least six 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

Cardiovascular risk factors at month 12 and month 24

Time frame: month 12 and month 24

Acute rejection episodes, gastrointestinal disorders and other adverse events 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

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.