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Fluvastatin After Heart Transplantation

NCT00421005 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2009-04-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

fluvastatin

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

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Angelo Branzi, MD · Alma Mater Studiorum University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00421005 on ClinicalTrials.gov