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Status unknownNCT00421005Updated Apr 29, 2009

Fluvastatin After Heart Transplantation

A Phase 4 interventional study of fluvastatin in Heart Transplantation and Hypercholesterolemia, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-29.

Sponsored by University of Bologna · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Transplantation
  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 56 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • De novo heart transplantation

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    1

    Fluvastatin 80mg

    Drug: fluvastatin

  • Active comparator
    2

    Fluvastatin 20, tapered up according to LDL concentration

    Drug: fluvastatin

Interventions

  • Drugfluvastatin

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

    Also known as: Lescol

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Study locations

1 site
  • Policlinico S.Orsola-Malpighi
    Bologna, 40138, Italy
07

References and documents

Publications

  • 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. PubMed 7637722 ↗
  • 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. PubMed 16303007 ↗
  • 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. PubMed 16797344 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00421005
Lead sponsor
University of Bologna
First posted
Jan 11, 2007
Start date
Nov 2004
Primary completion
Nov 2008 (estimated)
Completion
Nov 2008 (estimated)
Last update
Apr 29, 2009

Study contacts

Angelo Branzi, MD
study chair · Alma Mater Studiorum University of Bologna
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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