Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-05 @ 2:54 PM
Study NCT ID:
NCT00611260
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2008-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation
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': 'D004522', 'term': 'Educational Status'}, {'id': 'D019122', 'term': 'Meditation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2008-01-25', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias.', 'timeFrame': '3 month interval'}, {'measure': 'Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life.', 'timeFrame': '3 month intervals'}, {'measure': 'Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation.', 'timeFrame': '3 month intervals'}, {'measure': 'Increase in heart rate variability for patients participating in vipassana meditation training.', 'timeFrame': '3 month intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Meditation', 'Congestive Heart Failure', 'ICD', 'Cardiac Resynchronization Therapy'], 'conditions': ['Congestive Heart Failure', 'Cardiac Resynchronization Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ucdmc.ucdavis.edu/clinicaltrials/trialDetail.aspx?protocol=200715089', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.\n\nWe wish to test the following hypotheses:\n\n1. Vipassana meditation reduces the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure.\n2. Vipassana meditation improves the psychological profile in patients with CHF. In this study, subjects meeting the inclusion and exclusion criteria will be recruited into the study after obtaining informed consent. The subjects will then be randomized into either an experimental group ( Meditation) or into a control group (usual care).', 'detailedDescription': 'This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 85\n* All patients with NYHA class II to III congestive heart failure symptoms from ischemic and non-ischemic etiology who received a defibrillator at least 3 months prior to enrollment.\n* All patients with NYHA class III and IV symptoms, QRS complex of the ECG more than 120 ms, who received device for cardiac resynchronization at least 3 months prior to enrollment. These devices are placed when the two ventricles beat at slightly different times. These devices also have the capacity to record arrhythmias as the defibrillators.\n\nExclusion Criteria:\n\n* Patients with life expectancy less than 6 months from non-cardiac causes\n* Pregnant women\n* Smokers\n* History of major psychosis.\n* Significant chronic liver, renal and pulmonary disease\n* Active alcohol and drug abuse'}, 'identificationModule': {'nctId': 'NCT00611260', 'briefTitle': 'Improvement in Clinical Outcomes in Heart Failure Patients With ICDs That Practice Meditation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Does Meditation Improve Outcomes in Patients With Heart Failure Who Received Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators?', 'orgStudyIdInfo': {'id': '200715089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation Cohort', 'description': '25 patients will be given instruction in vipassana meditation. Vipassana meditation is thought to reduce the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure, and improve their overall psychological profile.', 'interventionNames': ['Behavioral: Vipassana Meditation practice and instruction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': '25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health.', 'interventionNames': ['Other: Standard Medical Care']}], 'interventions': [{'name': 'Vipassana Meditation practice and instruction', 'type': 'BEHAVIORAL', 'otherNames': ['Meditation + ICD'], 'description': '2-3 instructed meditation sessions per week in addition to standard medical care.', 'armGroupLabels': ['Meditation Cohort']}, {'name': 'Standard Medical Care', 'type': 'OTHER', 'otherNames': ['Standard of Care'], 'description': 'Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Uma Srivatsa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}