Trials / Unknown
UnknownNCT00421005
Fluvastatin After Heart Transplantation
Safety and Efficacy of Fluvastatin in Heart Transplant Recipients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- University of Bologna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fluvastatin | Fluvastatin 80 mg (Arm 1) vs. Fluvastatin 20 mg (Arm 2) increased according with LDL concentrations |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2008-11-01
- Completion
- 2008-11-01
- First posted
- 2007-01-11
- Last updated
- 2009-04-29
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00421005. Inclusion in this directory is not an endorsement.