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OpenTrials
Completed

NCT Number: NCT00176332

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Leipzig, Saxony, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Primary outcomes

  1. Inflammation in the blood and the skeletal muscle

  2. Vasculogenesis

  3. Endothelial function of the radial artery

Secondary outcomes

  1. Peak oxygen uptake

  2. Left ventricular function

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Aug 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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