Text Size

Fluvastatin After Heart Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Bologna.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00421005
First received: January 9, 2007
Last updated: April 28, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Hypercholesterolemia
 Drug: fluvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421005

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

Publications:

Responsible Party: University of Bologna
ClinicalTrials.gov Identifier: NCT00421005     History of Changes
Other Study ID Numbers: 126/2004/U/Sper
Study First Received: January 9, 2007
Last Updated: April 28, 2009
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fluvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013