BeTACTIC Study. Best Therapy After Cardiac Transplantation, the Italian Challenge. A multicenter, prospective, randomized, open-label study to compare the efficacy and safety of Everolimus and Mycophenolate (either mofetil or sodium) in association with Cyclosporine in patients with acute multiple/late rejection, cardiac allograft vasculopathy, renal dysfunction after cardiac transplantation - BeTACTIC

Conditions: Paitents will be enrolled at least one year after heart transplant
MedDRA version: 9.1Level: SOCClassification code 10007541

Registration Number: EUCTR2010-018353-36-IT

Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients eligible for inclusion have to fulfil all the following criteria: age >= 18 years at the time of enrolment; HTx at least 1 year before; be able and willing to give informed consent; baseline maintenance immunosuppression including CyA (for at least 1 month) at randomization; presence of one or more of the following conditions: 1) recurrent rejection within the first year (three or more treatments with additional steroids, either orally or intravenously, for acute rejection); 2) late (> 1 year after HTx) acute rejection treated with steroids; 3) cardiac allograft vasculopathy/chronic rejection, defined as follows: >50% stenosis of at least 1 vessel/branch, or diffuse disease, according to Gao criteria, and/or intimal thickness at IVUS >= 0.5 mm in at least 1 segment. Qualifying angiography/IVUS should be dated less than 1 year prior to randomization; 4) renal dysfunction, defined as GFR, calculated with MDRD formula, between 30 and 60 ml/min/1.73 square meters, or =/> 15% reduction of GFR within the last 12 months, confirmed by two or more measurements obtained at least two weeks apart
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- ongoing or planned pregnancy; - severe left ventricular dysfunction: ejection fraction <=30%; - severe renal insufficiency: GFR <= 30 ml/min/1.73 square meters; - proteinuria (total protein>= 800mg/day); - severe dyslipidemia: total cholesterol >350 mg/dl, triglycerides >750 mg/dl;- severe anemia: hemoglobin (Hb) < 10 g/dl; - platelet count < 100000/mm3; - white blood cell count <4000/mm3; - current cancer (with the exception of skin cancer); - history of prior cancer (except skin cancer) with a disease-free interval <3 years; - active hepatitis B or C (HBV-DNA positive, or HCV-RNA positive; or HBsAg positive or antiHCV positive associated with AST/ALT levels more than normal upper limit x 4); - need for oral anticoagulation; - known intolerance to any of the study drugs; - ongoing major infection (patient may be evaluated for enrolment after resolution); - ongoing acute rejection (patient may be evaluated for enrolment after resolution); - comorbidities that could independently reduce life expectancy. - baseline maintenance immunosuppression including Tacrolimus (pts may be evaluated at least 1 month after switching to CyA) - baseline maintenance immunosuppression including Everolimus or Sirolimus.