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Fluvastatin After Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00421005
Recruitment Status : Unknown
Verified April 2009 by University of Bologna.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2007
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
University of Bologna

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.

Condition or disease Intervention/treatment Phase
Heart Transplantation Hypercholesterolemia Drug: fluvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
Study Start Date : November 2004
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421005


Locations
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Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
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Study Chair: Angelo Branzi, MD Alma Mater Studiorum University of Bologna
Publications:
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Responsible Party: University of Bologna
ClinicalTrials.gov Identifier: NCT00421005    
Other Study ID Numbers: 126/2004/U/Sper
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases