Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 2:36 AM
Study NCT ID:
NCT01212705
Status:
UNKNOWN
Last Update Posted:
2010-10-01
First Post:
2010-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D002639', 'term': 'Cheyne-Stokes Respiration'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System 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'}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2010-09-30', 'studyFirstSubmitDate': '2010-09-30', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Chronic Heart Failure', 'Central Sleep Apnea', 'Cheyne-Stokes Respiration']}, 'descriptionModule': {'briefSummary': 'Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic heart failure with ejection fraction ≤45%\n* optimal medical treatment for at least 1 month\n* clinical diagnosis of Cheyne-Stokes respiration\n\nExclusion Criteria:\n\n* unstable heart failure\n* stroke\n* transient ischemic attack in last 6 months\n* pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance\n* severe chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT01212705', 'briefTitle': 'Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Effect of Adaptive Servoventilation on Cardiac Function, Exercise Tolerance and Quality of Life in Patients With Chronic Heart Failure and Cheyne-Stokes Respiration', 'orgStudyIdInfo': {'id': 'BW2126/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASV', 'interventionNames': ['Device: Adaptive servoventilation']}], 'interventions': [{'name': 'Adaptive servoventilation', 'type': 'DEVICE', 'description': 'Background expiratory positive airway pressure with some inspiratory pressure support when needed', 'armGroupLabels': ['ASV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'state': 'Szaserow 128', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Anna Kazimierczak', 'role': 'CONTACT', 'email': 'annakazimierczak@poczta.onet.pl', 'phone': '48 22 6818017'}, {'name': 'Krystian Krzyzanowski', 'role': 'CONTACT', 'email': 'krystian.krzyzanowski@gmail.com', 'phone': '48 512 356 207'}], 'overallOfficials': [{'name': 'Anna Kazimierczak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Institute of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}}}}