Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-08 @ 11:09 PM
Study NCT ID:
NCT03195660
Status:
TERMINATED
Last Update Posted:
2021-05-14
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.benjafield@resmed.com', 'phone': '+61 466 634 609', 'title': 'Adam Benjafield', 'organization': 'ResMed'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Study was terminated early; results were not analyzed.\n\nSix participants overall were consented for the study; four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ASV Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'timeFrame': '3 months', 'description': 'Average hours used per day', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prior to the follow-up period'}, {'type': 'SECONDARY', 'title': 'KCCQ-12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'timeFrame': '3 months', 'description': 'Change in KCCQ-12 score. Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) is a short questionnaire to evaluate quality of life in heart failure patients. All scores are scaled from 0-100 where low scares represent very poor health and high scores represent excellent health.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prior to the follow-up period'}, {'type': 'SECONDARY', 'title': 'Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'timeFrame': '3 months', 'description': 'Number of hospitalizations per subject', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prior to the follow-up period'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'timeFrame': '3 months', 'description': 'Number of deaths', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated prior to the follow-up period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'The study was terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Six participants overall were consented for the study, and baseline data on these participants was collected at the baseline visit. Following on from this, four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ASV Therapy', 'description': 'ASV Therapy\n\nASV Therapy: AirCurve 10 ASV device set up in AutoSet mode'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ejection fraction', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '71'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Six participants overall were consented for the study, and baseline data on these participants was collected at the baseline visit. Following on from this, four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-28', 'size': 650360, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-09T15:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single-arm, un-blinded, multi-center'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Funding for study was withdrawn', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2017-06-20', 'resultsFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-20', 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASV Adherence', 'timeFrame': '3 months', 'description': 'Average hours used per day'}], 'secondaryOutcomes': [{'measure': 'KCCQ-12', 'timeFrame': '3 months', 'description': 'Change in KCCQ-12 score. Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) is a short questionnaire to evaluate quality of life in heart failure patients. All scores are scaled from 0-100 where low scares represent very poor health and high scores represent excellent health.'}, {'measure': 'Hospitalizations', 'timeFrame': '3 months', 'description': 'Number of hospitalizations per subject'}, {'measure': 'Death', 'timeFrame': '3 months', 'description': 'Number of deaths'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['adaptive servo-ventilation', 'ASV', 'HFpEF'], 'conditions': ['Heart Failure With Normal Ejection Fraction', 'Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.', 'detailedDescription': 'Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036).\n\nAlthough the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 18 years or older\n2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)\n3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:\n\n 1. Dyspnea at rest or with minimal exertion AND\n 2. Treatment with at least one dose of IV diuretic or ultrafiltration AND\n 3. At least two of the following signs and symptoms:\n\n i. Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level: A. No current atrial fibrillation (AFib): BNP≥100 pg/mL or NT pro- BNP≥300 pg/mL OR B. Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL\n4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)\n5. Patient is able to fully understand study information and sign informed consent\n\nExclusion Criteria:\n\n1. Right-sided heart failure without left-sided failure\n2. Current chronic use (within 4 weeks of study entry) of any PAP therapy (eg, CPAP, APAP, or bi-level) or contraindicated for PAP therapy\n3. Sustained systolic blood pressure \\<80 mmHg at baseline\n4. Complex congenital heart disease\n5. Constrictive pericarditis\n6. Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)\n7. Transient ischemic attack (TIA) or Stroke within 3 months prior to study entry\n8. Definite clinically evident acute myocardial infarction within 3 months of study entry\n9. Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas\n10. Moderate or greater valvular heart disease as the primary reason for heart failure\n11. Pregnant, or planning to become pregnant during the study period\n12. In the opinion of the investigator, the index acute decompensated HF event was due primarily to uncontrolled AFib with fast ventricular response rate\n13. Inability to comply with planned study procedures'}, 'identificationModule': {'nctId': 'NCT03195660', 'acronym': 'CAT-PEF', 'briefTitle': 'Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study', 'orgStudyIdInfo': {'id': 'MA-16-12-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASV Therapy', 'description': 'ASV Therapy', 'interventionNames': ['Device: ASV Therapy']}], 'interventions': [{'name': 'ASV Therapy', 'type': 'DEVICE', 'otherNames': ['AirCurve 10 ASV'], 'description': 'AirCurve 10 ASV device set up in AutoSet mode', 'armGroupLabels': ['ASV Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Heart and Vascular Institute', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'Heart and Diabetes Center - West Rhine-Westphalia', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}], 'overallOfficials': [{'name': "Christopher O'Connor, MD", 'role': 'STUDY_CHAIR', 'affiliation': 'Inova Heart and Vascular Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}