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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
University of Leipzig
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring chronic heart failure, rosuvastatin, endothelial function, skeletal muscle

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology

Outcomes

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

Full Information

First Posted
September 10, 2005
Last Updated
July 31, 2007
Sponsor
University of Leipzig
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00176332
Brief Title
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
chronic heart failure, rosuvastatin, endothelial function, skeletal muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Primary Outcome Measure Information:
Title
Inflammation in the blood and the skeletal muscle
Title
Vasculogenesis
Title
Endothelial function of the radial artery
Secondary Outcome Measure Information:
Title
Peak oxygen uptake
Title
Left ventricular function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer P Hambrecht, MD
Organizational Affiliation
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

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

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