Status:
UNKNOWN
Fluvastatin After Heart Transplantation
Lead Sponsor:
University of Bologna
Conditions:
Heart Transplantation
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- De novo heart transplantation
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00421005
Start Date
November 1 2004
End Date
November 1 2008
Last Update
April 29 2009
Active Locations (1)
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1
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138