Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
Impact of Three Months of Rosuvastatin Treatment on Peripheral Endothelial Function, Inflammatory Markers in the Blood and the Skeletal Muscle and on Postnatal Vasculogenesis in Patients With Severe Chronic Heart Failure
1 other identifier
interventional
40
1 country
1
Brief Summary
Statin therapy has been shown to efficiently reduce mortality in patients with coronary artery disease and myocardial infarction, partially as a result of the lipid-lowering properties of statins. However, especially the pleiotropic effects of statins, e.g. their anti-inflammatory and anti-oxidative properties, might be of interest in the treatment of patients with chronic heart failure that are limited in their exercise capacity due to alterations of the skeletal muscle and peripheral endothelial dysfunction. Aim of this trial is therefore to assess the effects of three months of rosuvastatin treatment on markers of inflammation and oxidative stress in the skeletal muscle and the blood, on postnatal vasculogenesis, and endothelial function of the radial artery in patients with severe chronic heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Mar 2004
Typical duration for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 1, 2007
July 1, 2007
September 10, 2005
July 31, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Inflammation in the blood and the skeletal muscle
Vasculogenesis
Endothelial function of the radial artery
Secondary Outcomes (2)
Peak oxygen uptake
Left ventricular function
Interventions
Eligibility Criteria
You may qualify if:
- chronic heart failure (NYHA class III or IV)
- peak oxygen uptake \<20 mL/min/kg body weight
- left ventricular ejection fraction \<30 %
- left ventricular end-diastolic diameter \>55 mm
- stable medication within the last 4 weeks
You may not qualify if:
- elevated GOT and GPT levels as a sign of hepatic dysfunction
- elevated creatinine levels as a sign of renal dysfunction
- insulin-dependent diabetes mellitus
- arterial hypertension
- muscle disease or elevated CK levels
- treatment with fibrates
- co-treatment with drugs that are metabolized by Cyp3A4
- diseases that disallow a participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- AstraZenecacollaborator
Study Sites (1)
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, 04289, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer P Hambrecht, MD
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
March 1, 2004
Study Completion
December 1, 2006
Last Updated
August 1, 2007
Record last verified: 2007-07