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

NCT ID: NCT00176332

Last Updated: 2007-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rosuvastatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Principal Investigators

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Rainer P Hambrecht, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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121/2003

Identifier Type: -

Identifier Source: org_study_id