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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

Tracking Information
First Submitted Date  ICMJE January 9, 2007
First Posted Date  ICMJE January 11, 2007
Last Update Posted Date April 29, 2009
Study Start Date  ICMJE November 2004
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluvastatin After Heart Transplantation
Official Title  ICMJE Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Heart Transplantation
  • Hypercholesterolemia
Intervention  ICMJE Drug: fluvastatin
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
Other Name: Lescol
Study Arms  ICMJE
  • Experimental: 1
    Fluvastatin 80mg
    Intervention: Drug: fluvastatin
  • Active Comparator: 2
    Fluvastatin 20, tapered up according to LDL concentration
    Intervention: Drug: fluvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: April¬†28,¬†2009)
56
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE November 2008
Estimated Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00421005
Other Study ID Numbers  ICMJE 126/2004/U/Sper
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Bologna
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Bologna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Angelo Branzi, MD Alma Mater Studiorum University of Bologna
PRS Account University of Bologna
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP