Fluvastatin After Heart Transplantation

Phase 4

• Conditions: Heart Transplantation; Hypercholesterolemia
• Interventions: Drug: fluvastatin

• Registration Number: NCT00421005
• Lead Sponsor: University of Bologna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-28
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	fluvastatin	Fluvastatin 80mg
2	fluvastatin	Fluvastatin 20, tapered up according to LDL concentration

Trial Locations

Locations (1)

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy