Fluvastatin After Heart Transplantation

• Status: Unknown status
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bologna
• Treatments: Fluvastatin

Criteria

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