Overview

This trial is active, not recruiting.

Conditions heart transplantation, hypercholesterolemia
Treatment fluvastatin
Phase phase 4
Sponsor University of Bologna
Start date November 2004
End date November 2008
Trial size 56 participants
Trial identifier NCT00421005, 126/2004/U/Sper

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Fluvastatin 80mg
fluvastatin Lescol
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
(Active Comparator)
Fluvastatin 20, tapered up according to LDL concentration
fluvastatin Lescol
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations

Eligibility Criteria

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

Additional Information

Official title Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by University of Bologna.