Fluvastatin After Heart Transplantation

Hypercholesterolemia Clinical Trial

Official title:

Safety and Efficacy of Fluvastatin in Heart Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00421005
• Other study ID #: 126/2004/U/Sper
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 9, 2007
• Last updated: April 28, 2009
• Start date: November 2004
• Est. completion date: November 2008

Study information

• Verified date: April 2009
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Transplantation
• Hypercholesterolemia

Intervention

Drug:
• fluvastatin
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

Holdaas H, Fellström B, Cole E, Nyberg G, Olsson AG, Pedersen TR, Madsen S, Grönhagen-Riska C, Neumayer HH, Maes B, Ambühl 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. — View Citation

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. — View Citation