Fluvastatin After Heart Transplantation

Safety and Efficacy of Fluvastatin in Heart Transplant Recipients

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421005

Enrollment

Registered

2007-01-11

Start date

2004-11-30

Completion date

2008-11-30

Last updated

2009-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation, Hypercholesterolemia

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.

Interventions

DRUGfluvastatin

Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026