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Fluvastatin After Heart Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by University of Bologna.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Bologna Identifier:
First received: January 9, 2007
Last updated: April 28, 2009
Last verified: April 2009
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.

Condition Intervention Phase
Heart Transplantation
Drug: fluvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Fluvastatin in Heart Transplant Recipients

Resource links provided by NLM:

Further study details as provided by University of Bologna:

Enrollment: 56
Study Start Date: November 2004
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fluvastatin 80mg
Drug: fluvastatin
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
Other Name: Lescol
Active Comparator: 2
Fluvastatin 20, tapered up according to LDL concentration
Drug: fluvastatin
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
Other Name: Lescol


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00421005

Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Study Chair: Angelo Branzi, MD Alma Mater Studiorum University of Bologna
  More Information

Responsible Party: University of Bologna Identifier: NCT00421005     History of Changes
Other Study ID Numbers: 126/2004/U/Sper
Study First Received: January 9, 2007
Last Updated: April 28, 2009

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on April 26, 2017