Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00176332
Status:
COMPLETED
Last Update Posted:
2007-08-01
First Post:
2005-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-31', 'studyFirstSubmitDate': '2005-09-10', 'studyFirstSubmitQcDate': '2005-09-10', 'lastUpdatePostDateStruct': {'date': '2007-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammation in the blood and the skeletal muscle'}, {'measure': 'Vasculogenesis'}, {'measure': 'Endothelial function of the radial artery'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen uptake'}, {'measure': 'Left ventricular function'}]}, 'conditionsModule': {'keywords': ['chronic heart failure', 'rosuvastatin', 'endothelial function', 'skeletal muscle'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': '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.\n\nAim 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.', 'detailedDescription': 'A total of 40 patients with severe chronic heart failure are prospectively randomized to either 3 months of rosuvastatin or placebo treatment.\n\nBefore 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic heart failure (NYHA class III or IV)\n* peak oxygen uptake \\<20 mL/min/kg body weight\n* left ventricular ejection fraction \\<30 %\n* left ventricular end-diastolic diameter \\>55 mm\n* stable medication within the last 4 weeks\n\nExclusion Criteria:\n\n* elevated GOT and GPT levels as a sign of hepatic dysfunction\n* elevated creatinine levels as a sign of renal dysfunction\n* insulin-dependent diabetes mellitus\n* arterial hypertension\n* muscle disease or elevated CK levels\n* treatment with fibrates\n* co-treatment with drugs that are metabolized by Cyp3A4\n* diseases that disallow a participation in the study'}, 'identificationModule': {'nctId': 'NCT00176332', 'briefTitle': 'Impact of Rosuvastatin on Endothelial Function and Inflammation in Patients With Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '121/2003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rosuvastatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Rainer P Hambrecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}]}}}