Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-06 @ 6:00 AM
Study NCT ID:
NCT05646056
Status:
COMPLETED
Last Update Posted:
2024-10-24
First Post:
2022-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2022-11-23', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System', 'timeFrame': '14 days', 'description': 'Correlation between in-clinic 6-minute walk test (6MWT) measures of exercise tolerance and ambulatory electrocardiogram (ECG)'}], 'primaryOutcomes': [{'measure': 'To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk', 'timeFrame': '14 days', 'description': 'Percentage of complete daily datasets transmitted to the Pyxida System database at the end of the monitoring period'}], 'secondaryOutcomes': [{'measure': 'To evaluate subject compliance and experience using the Pyxida System', 'timeFrame': '14 days', 'description': 'Outcomes of subject post-study survey'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiomyopathy, Hypertrophic', 'Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms', 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening\n* Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening\n* Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening\n\nKey Exclusion Criteria:\n\n* Active neurological disorder, such as uncontrolled seizure disorder.\n* Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.\n* Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity'}, 'identificationModule': {'nctId': 'NCT05646056', 'briefTitle': 'A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prolaio'}, 'officialTitle': 'A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System', 'orgStudyIdInfo': {'id': 'PRO-001-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'interventionNames': ['Device: Software']}, {'label': 'Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I', 'interventionNames': ['Device: Software']}, {'label': 'Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I', 'interventionNames': ['Device: Software']}, {'label': 'Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II', 'interventionNames': ['Device: Software']}], 'interventions': [{'name': 'Software', 'type': 'DEVICE', 'description': 'Observation only', 'armGroupLabels': ['Asymptomatic subjects with a history of heart failure (HF) and NYHA Class I', 'Asymptomatic subjects with a history of left ventricular hypertrophy (LVH) and NYHA Class I', 'Healthy subjects', 'Subjects with a history of hypertrophic cardiomyopathy (HCM) and NYHA Class I, II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Michael Koren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacksonville Center For Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prolaio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}