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...
Date First Received: January 9, 2007
Last Updated: April 28, 2009
Verified by: University of Bologna, April 2009
Clinical Trial Phase: Phase 4 | Start Date: November 2004
Overall Status: Active, not recruiting
Estimated Enrollment: 56
Brief Summary
Official Title: “Safety and Efficacy of Fluvastatin in Heart Transplant Recipients”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- Drug: fluvastatin
- Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Fluvastatin 80mg
- Active Comparator: 2
- Fluvastatin 20, tapered up according to LDL concentration
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Bologna
Overall Clinical Trial Officials and Contacts
Angelo Branzi, MD Study Chair Alma Mater Studiorum University of Bologna
Related Publications
References
Kobashigawa JA, Katznelson S, Laks H, Johnson JA, Yeatman L, Wang XM, Chia D, Terasaki PI, Sabad A, Cogert GA, et al. Effect of pravastatin on outcomes after cardiac transplantation. N Engl J Med. 1995 Sep 7;333(10):621-7.
Holdaas H, Fellstrom B, Cole E, Nyberg G, Olsson AG, Pedersen TR, Madsen S, Gronhagen-Riska C, Neumayer HH, Maes B, Ambuhl P, Hartmann A, Staffler B, Jardine AG; Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators. Long-term cardiac outcomes in renal transplant recipients receiving fluvastatin: the ALERT extension study. Am J Transplant. 2005 Dec;5(12):2929-36. Erratum in: Am J Transplant. 2006 Aug;6(8):1986.
Grigioni F, Carigi S, Potena L, Fabbri F, Russo A, Musuraca AC, Coccolo F, Magnani G, Ortolani P, Leone O, Arpesella G, Magelli C, Branzi A. Long-term safety and effectiveness of statins for heart transplant recipients in routine clinical practice. Transplant Proc. 2006 Jun;38(5):1507-10.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421005
Study ID Number: 126/2004/U/Sper
ClinicalTrials.gov Identifier: NCT00421005
Health Authority: Italy: Ethics Committee
Clinical Trials Authorship and Review
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