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.
- De novo heart transplantation
- 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
|Official title||Safety and Efficacy of Fluvastatin in Heart Transplant Recipients|
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