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Fluvastatin After Heart Transplantation

NCT ID: NCT00421005

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Fluvastatin 80mg

Group Type EXPERIMENTAL

fluvastatin

Intervention Type DRUG

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

2

Fluvastatin 20, tapered up according to LDL concentration

Group Type ACTIVE_COMPARATOR

fluvastatin

Intervention Type DRUG

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

Interventions

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fluvastatin

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

Intervention Type DRUG

Other Intervention Names

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Lescol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bologna

OTHER

Sponsor Role lead

Principal Investigators

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Angelo Branzi, MD

Role: STUDY_CHAIR

Alma Mater Studiorum University of Bologna

Locations

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Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 7637722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16303007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16797344 (View on PubMed)

Other Identifiers

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126/2004/U/Sper

Identifier Type: -

Identifier Source: org_study_id