Fluvastatin After Heart Transplantation

University of Bologna

Status and phase: Unknown; Phase 4

Conditions: Hypercholesterolemia; Heart Transplantation

Treatments: Drug: fluvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00421005

126/2004/U/Sper

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

1

Experimental group

Description:

Fluvastatin 80mg

Treatment:

Drug: fluvastatin

2

Active Comparator group

Description:

Fluvastatin 20, tapered up according to LDL concentration

Treatment:

Drug: fluvastatin