Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT00563693
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2007-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002639', 'term': 'Cheyne-Stokes Respiration'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2007-11-23', 'studyFirstSubmitQcDate': '2007-11-23', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ejection fraction (measured with echocardiography) and inflammatory markers', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': '6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'cheyne stokes respiration', 'adaptive servo ventilator'], 'conditions': ['Heart Failure', 'Cheyne Stokes Respiration']}, 'descriptionModule': {'briefSummary': 'An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.', 'detailedDescription': 'Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.\n\nSeveral patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ejection fraction \\<40%\n* NYHA class III-IV\n* Optimized therapy with drugs\n* Cheyne stokes respiration pattern \\> 25% while sleeping\n* Age \\< 85 years\n* clinical stability the last month before inclusion.\n\nExclusion Criteria:\n\n* CABG less then 6 months ago\n* PCI treatment less then 3 months ago\n* Unstable angina pectoris\n* Acute coronary syndrome less then 3 months ago\n* Stroke less then 6 weeks ago\n* Thoracal myopathy\n* Advanced COPD'}, 'identificationModule': {'nctId': 'NCT00563693', 'acronym': '3C', 'briefTitle': 'Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).', 'orgStudyIdInfo': {'id': '1.2007.980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'The patients use ASV', 'interventionNames': ['Device: ASV', 'Other: without Autoset CS2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Patients without ASV', 'interventionNames': ['Other: without Autoset CS2']}], 'interventions': [{'name': 'ASV', 'type': 'DEVICE', 'otherNames': ['AutoSet CS2'], 'description': 'Adaptive servo ventilator', 'armGroupLabels': ['A']}, {'name': 'without Autoset CS2', 'type': 'OTHER', 'description': 'without Autoset CS2', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fredrikstad', 'country': 'Norway', 'facility': 'Sykehuset ostfold Fredrikstad', 'geoPoint': {'lat': 59.2181, 'lon': 10.9298}}], 'overallOfficials': [{'name': 'Arild Hetland, cardiologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Arild Hetland', 'investigatorAffiliation': 'University of Oslo'}}}}