Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-29 @ 10:30 AM
Study NCT ID:
NCT04814134
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardionomic STOP-ADHF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be enrolled in CPNS treatment arm or to the control arm. Treatment with CPNS system includes endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. Subjects in the control arm will receive the available standard treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Measures', 'timeFrame': '6 months', 'description': 'The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Neurostimulation', 'Contractility', 'Right Pulmonary Artery'], 'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.', 'detailedDescription': 'The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF).\n\nThe CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator.\n\nApproximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to hospital with a principal diagnosis of ADHF\n* BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL\n* LVEF ≤ 50%\n* At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent)\n\nExclusion Criteria:\n\n* Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment\n* Requires mechanical support\n* Cardiogenic shock or impending cardiogenic shock\n* Systolic blood pressure \\< 80mmHg or \\> 140mmHg\n* Symptomatic hypotension\n* eGFR \\< 25 mL/min/1.732'}, 'identificationModule': {'nctId': 'NCT04814134', 'briefTitle': 'Cardionomic STOP-ADHF Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardionomic Inc.'}, 'officialTitle': 'The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'CLN-1051-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPNS Therapy', 'description': 'Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care', 'interventionNames': ['Device: CPNS Therapy', 'Other: Standard of care']}, {'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Available standard treatment', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'CPNS Therapy', 'type': 'DEVICE', 'description': 'Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care', 'armGroupLabels': ['CPNS Therapy']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Available standard treatment', 'armGroupLabels': ['CPNS Therapy', 'Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '44309', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Summa Health', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital South', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TriStar Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical City Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3435CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Punta Pacifica', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardionomic Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}