Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT01939795
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
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'}]}}, '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': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2013-03-27', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sympathetic nerve activity', 'timeFrame': '4 months', 'description': 'Sympathetic nerve activity will be assessed by microneurography'}], 'secondaryOutcomes': [{'measure': 'Peak oxygen consumption', 'timeFrame': '4 months', 'description': 'Peak oxygen consumption will be determined by cardiopulmonary exercise testing'}, {'measure': 'Quality of life', 'timeFrame': '4 months', 'description': 'Quality of life will be assessed by questionnaire'}, {'measure': 'Blood inflammatory markers', 'timeFrame': '4 months', 'description': 'Blood inflammatory markers will be assessed by venipuncture'}, {'measure': 'skeletal muscle strength', 'timeFrame': '4 months', 'description': 'Muscular evaluation will be done muscle gene expression'}, {'measure': 'Muscle Blood Flow', 'timeFrame': '4 months', 'description': 'Forearm blood flow will be assessed by venous occlusion plethysmography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac resynchronization therapy (CRT)'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* QRS\\> 150 ms or 120-150ms associated dyssynchrony\n* The etiology can be idiopathic, ischemic, hypertensive and Chagas' disease\n* Ejection fraction \\<35%\n* The optimal pharmacological treatment for heart failureExclusion Criteria:\n\nExclusion Criteria:\n\n* Patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases\n* Patients with contraindications to implant a cardiac pacemaker\n* Pregnancy\n* New York Heart Association functional class IV\n* Atrial fibrillation"}, 'identificationModule': {'nctId': 'NCT01939795', 'briefTitle': 'Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'PT & CRT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Healthy People', 'description': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'Untrained CRT', 'description': 'Untrained CRT patients', 'interventionNames': ['Other: exercise training and/or CRT']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise trained + CRT', 'description': 'Exercise-trained CRT patients', 'interventionNames': ['Other: exercise training and/or CRT']}], 'interventions': [{'name': 'exercise training and/or CRT', 'type': 'OTHER', 'otherNames': ['Untrained CRT patients', 'Exercise-trained CRT patients'], 'description': 'Three 40-minute exercise sessions per week on a treadmill for four months', 'armGroupLabels': ['Exercise trained + CRT', 'Untrained CRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Thais Simoes Nobre Pires Santos', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Carlos E Negrao, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'InCor, HCFMUSP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd student', 'investigatorFullName': 'Thaís Simões Nobre Pires Santos', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}