Fluvastatin After Heart Transplantation

University of Bologna56 enrolled

Overview

Statin therapy is a treatment with a proven positive impact on survival after heart transplantation. However, it is unclear whether the beneficial effect of this class of drugs depends solely on their LDL-lowering properties or on anti-inflammatory and immuno-modulatory properties. Thus, this study was designed to compare safety and efficacy of two different strategies: 1. high fixed statin dose vs. 2. low starting dose with LDL-driven doses adjustments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Heart Transplantation Hypercholesterolemia

Interventions

fluvastatinDRUG

Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * De novo heart transplantation Exclusion Criteria: * Known allergy/intolerance to fluvastatin; * Preexisting neuromuscular disorders; * Significant liver disease and/or elevation of transaminase exceeding 3 times the ULN * Severe renal impairment : creatinine \> 3 mg/dL * Intellectual/cognitive impairment likely to compromise informed consent or adherence to protocol or age \<18 years. * Patients refusal * Pregnancy

Locations (1)

Policlinico S.Orsola-Malpighi

Bologna, Italy

Data from ClinicalTrials.gov

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