Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-01 @ 4:39 PM
Study NCT ID:
NCT02244957
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2014-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA
Sponsor:
Organization:
Raw JSON
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The dual diagnosis of these two conditions is referred to as Overlap Syndrome.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Right Ventricular Remodeling Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'description': 'Subjects with only Chronic Obstructive Pulmonary Disease (COPD).'}, {'id': 'OG001', 'title': 'Overlap Syndrome', 'description': 'Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3747', 'spread': '0.06335', 'groupId': 'OG000'}, {'value': '0.2817', 'spread': '0.03630', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Six months', 'description': 'Defined as the ratio between RVMI and RV end-diastolic volume index using MRI', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'one subject was dropped due to lack of efficacy'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Right Ventricular End Systolic and Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Right Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Myocardial Extracellular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Remodeling Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': 'Six months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Left Ventricular End Systolic and Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'MRI', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Serum C-reactive Protein Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'blood test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Serum Tumor Necrosis Factor-alpha Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'blood test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Serum Interleukin-6 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'blood test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Serum Intercellular Adhesion Molecule-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'blood test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Serum P-selectin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'Blood test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Urine Catecholamine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'Urine test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': '6 Minute Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'Low-grade physical activity test', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': "Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.'}], 'timeFrame': '6 months', 'description': 'Questionnaire', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected as study was terminated prior to randomization'}, {'type': 'SECONDARY', 'title': 'Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bi-level Positive Airway Pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)\n\nBi-level positive airway pressure (BPAP): Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.'}, {'id': 'OG001', 'title': 'Nocturnal Oxygen', 'description': 'Nocturnal oxygen\n\nNocturnal oxygen: Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. 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The dual diagnosis of these two conditions is referred to as Overlap Syndrome.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Obstructive Pulmonary Disease (COPD)', 'description': 'Subjects with only Chronic Obstructive Pulmonary Disease (COPD).'}, {'id': 'BG001', 'title': 'Overlap Syndrome', 'description': 'Subjects with simultaneous Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD). The dual diagnosis of these two conditions is referred to as Overlap Syndrome.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'one subject was dropped due to lack of efficacy'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2014-03-25', 'size': 541155, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-28T13:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2014-09-15', 'resultsFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2014-09-16', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-13', 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Right Ventricular Remodeling Index', 'timeFrame': 'Six months', 'description': 'Defined as the ratio between RVMI and RV end-diastolic volume index using MRI'}], 'secondaryOutcomes': [{'measure': 'Right Ventricular Mass Index', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Right Ventricular End Systolic and Diastolic Volume', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Right Ventricular Ejection Fraction', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Myocardial Extracellular Volume', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Left Ventricular Remodeling Index', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Left Ventricular Mass Index', 'timeFrame': 'Six months', 'description': 'MRI'}, {'measure': 'Left Ventricular End Systolic and Diastolic Volume', 'timeFrame': '6 months', 'description': 'MRI'}, {'measure': 'Left Ventricular Ejection Fraction', 'timeFrame': '6 months', 'description': 'MRI'}, {'measure': 'Serum C-reactive Protein Level', 'timeFrame': '6 months', 'description': 'blood test'}, {'measure': 'Serum Tumor Necrosis Factor-alpha Level', 'timeFrame': '6 months', 'description': 'blood test'}, {'measure': 'Serum Interleukin-6 Level', 'timeFrame': '6 months', 'description': 'blood test'}, {'measure': 'Serum Intercellular Adhesion Molecule-1', 'timeFrame': '6 months', 'description': 'blood test'}, {'measure': 'Serum P-selectin Level', 'timeFrame': '6 months', 'description': 'Blood test'}, {'measure': 'Urine Catecholamine Level', 'timeFrame': '6 months', 'description': 'Urine test'}, {'measure': '6 Minute Walk Distance', 'timeFrame': '6 months', 'description': 'Low-grade physical activity test'}, {'measure': "Quality of Life Score Through St. George's Respiratory Questionnaire (SGRQ)", 'timeFrame': '6 months', 'description': 'Questionnaire'}, {'measure': 'Degree of Daytime Sleepiness Through Epworth Sleepiness Scale (ESS)', 'timeFrame': '6 months', 'description': 'Questionnaire'}, {'measure': 'Sleep Quality Through Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '6 months', 'description': 'Questionnaire'}, {'measure': 'General Health Status Through Short Form 36 (SF-36) Health Survey', 'timeFrame': '6 months', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Chronic Obstructive Pulmonary Disease', 'Overlap Syndrome']}, 'descriptionModule': {'briefSummary': 'The coexistence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population.The investigators propose to conduct this study that aims: (1) to compare right and left ventricular hemodynamic parameters using cardiac magnetic resonance imaging (MRI) in overlap syndrome vs. COPD only and OSA only; (2) to compare the effects of bi-level positive airway pressure (BPAP) vs. nocturnal oxygen therapy (NOT) on right ventricular (RV) hemodynamics in overlap syndrome.\n\nThis study will allow us to test the hypothesis: (1) Patients with overlap syndrome have more RV dysfunction than those with COPD only or OSA only; (2) treatment of both hypoxemia and hypercapnia during sleep will improve RV hemodynamics compared with treatment of hypoxemia alone in patients with overlap syndrome.', 'detailedDescription': 'Despite the high prevalence of overlap syndrome, few data are available on its pathophysiology and clinical consequences of these patients. Overlap syndrome has recently been reported to have excess cardiovascular mortality compared with COPD alone. However, no study has evaluated the mechanisms of excess cardiovascular mortality in untreated overlap syndrome. In addition, no prospective, randomized, controlled data are currently available on treatment of overlap syndrome.\n\nThis study is divided into two parts. The first part (Part 1) is a cross-sectional cohort study comparing subjects with overlap syndrome to those with COPD alone and those with OSA alone. Patients with COPD and OSA overlap syndrome will be evaluated by an overnight sleep study, cardiac MRI, serum inflammatory biomarker, urine catecholamine level, pulmonary function test, and questionnaires of sleep and health related quality of life. These measurement will be compared between overlap syndrome and control groups with either COPD or OSA alone.\n\nThe second part (Part 2) of the study is a prospective, parallel-group, randomized, controlled pilot study examining the effect of BPAP (and nocturnal oxygen if needed) vs. nocturnal oxygen therapy alone in patients with overlap syndrome (20 subjects in each treatment arm). The same measurement done during Part 1 will be repeated to evaluate the treatment effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both men and women with age more than 18 years.\n* Known diagnosis of stable COPD (GOLD stage 2 or higher) or OSA.\n\nExclusion Criteria:\n\n* Already using continuous positive airway pressure (CPAP), BPAP device, or nocturnal oxygen.\n* Known or suspected renal failure with estimated Glomerular filtration (GFR) \\<50 ml/min/1.73 m2 or serum creatinine \\> 1.5 mg/dl.\n* Chronic atrial fibrillation or frequent premature ventricular contraction (\\> 10 beats per hour)\n* Women known to be pregnant or planning to be pregnant in next 6 months.\n* Known contraindication to MRI: cardiac pacemaker, metallic heart valves, metallic implants, history of claustrophobia.\n* If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.\n* Uncontrolled COPD or acute COPD exacerbation.\n* Unstable cardiac diseases.\n* Known chronic inflammatory diseases like lupus or active infection.'}, 'identificationModule': {'nctId': 'NCT02244957', 'briefTitle': 'Right Ventricular Hemodynamics Using Cardiac MRI in Patients COPD and OSA', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Right Ventricular Hemodynamics Using Cardiac Magnetic Resonance Imaging in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)', 'orgStudyIdInfo': {'id': 'UCSD140959'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bi-level positive airway pressure (BPAP)', 'description': 'Bi-level positive airway pressure (BPAP)', 'interventionNames': ['Device: Bi-level positive airway pressure (BPAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nocturnal oxygen', 'description': 'Nocturnal oxygen', 'interventionNames': ['Drug: Nocturnal oxygen']}], 'interventions': [{'name': 'Bi-level positive airway pressure (BPAP)', 'type': 'DEVICE', 'otherNames': ['BPAP'], 'description': 'Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations \\<88% while on stable bi-level settings.', 'armGroupLabels': ['Bi-level positive airway pressure (BPAP)']}, {'name': 'Nocturnal oxygen', 'type': 'DRUG', 'otherNames': ['NOT'], 'description': 'Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.', 'armGroupLabels': ['Nocturnal oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Robert L Owens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Robert L. Owens', 'investigatorAffiliation': 'University of California, San Diego'}}}}