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Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176332
First Posted: September 15, 2005
Last Update Posted: August 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
University of Leipzig
  Purpose

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.


Condition Intervention Phase
Heart Failure Drug: rosuvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Inflammation in the blood and the skeletal muscle
  • Vasculogenesis
  • Endothelial function of the radial artery

Secondary Outcome Measures:
  • Peak oxygen uptake
  • Left ventricular function

Estimated Enrollment: 40
Study Start Date: March 2004
Study Completion Date: December 2006
Detailed Description:

A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment.

Before and after the intervention period maximal exercise capacity is measured by ergospirometry and endothelial function is determined by high-resolution A-mode ultrasound. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for inflammatory markers, measures of oxidative stress and vasculogenesis. Blood samples are assessed with regard to markers of inflammation and oxidative stress as well.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176332


Locations
Germany
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
University of Leipzig
AstraZeneca
Investigators
Principal Investigator: Rainer P Hambrecht, MD University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
  More Information

ClinicalTrials.gov Identifier: NCT00176332     History of Changes
Other Study ID Numbers: 121/2003
First Submitted: September 10, 2005
First Posted: September 15, 2005
Last Update Posted: August 1, 2007
Last Verified: July 2007

Keywords provided by University of Leipzig:
chronic heart failure
rosuvastatin
endothelial function
skeletal muscle

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors