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Fluvastatin After Heart Transplantation

Primary Purpose

Heart Transplantation, Hypercholesterolemia

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
fluvastatin
Sponsored by
University of Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico S.Orsola-Malpighi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Fluvastatin 80mg

Fluvastatin 20, tapered up according to LDL concentration

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 9, 2007
Last Updated
April 28, 2009
Sponsor
University of Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT00421005
Brief Title
Fluvastatin After Heart Transplantation
Official Title
Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
November 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Bologna

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Transplantation, Hypercholesterolemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fluvastatin 80mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fluvastatin 20, tapered up according to LDL concentration
Intervention Type
Drug
Intervention Name(s)
fluvastatin
Other Intervention Name(s)
Lescol
Intervention Description
Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Branzi, MD
Organizational Affiliation
Alma Mater Studiorum University of Bologna
Official's Role
Study Chair
Facility Information:
Facility Name
Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
7637722
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. doi: 10.1056/NEJM199509073331003.
Results Reference
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PubMed Identifier
16303007
Citation
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. doi: 10.1111/j.1600-6143.2005.01105.x. Erratum In: Am J Transplant. 2006 Aug;6(8):1986.
Results Reference
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PubMed Identifier
16797344
Citation
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. doi: 10.1016/j.transproceed.2006.02.071.
Results Reference
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Fluvastatin After Heart Transplantation

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