Fluvastatin After Heart Transplantation
This trial is active, not recruiting.
|Conditions||heart transplantation, hypercholesterolemia|
|Sponsor||University of Bologna|
|Start date||November 2004|
|End date||November 2008|
|Trial size||56 participants|
|Trial identifier||NCT00421005, 126/2004/U/Sper|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants at least 18 years old.
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
|Official title||Safety and Efficacy of Fluvastatin in Heart Transplant Recipients|
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