Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-09 @ 9:37 PM
Study NCT ID:
NCT06122961
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2023-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-08', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High sensitivity C-reactive protein (hsCRP) greater than or equal to 2 mg/L (yes/ no)', 'timeFrame': 'At visit (day 0)', 'description': 'Count of patient'}], 'secondaryOutcomes': [{'measure': 'Interleukin 6 (IL-6)', 'timeFrame': 'At visit (day 0)', 'description': 'pg/ml'}, {'measure': 'N-terminal prohormone of brain natriuretic peptide (NT-proBNP)', 'timeFrame': 'At visit (day 0)', 'description': 'pg/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk', 'Heart Failure', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study will collect medical and background information from participants with diseases that affect the heart and blood vessels (cardiovascular disease). Participants will continue their normal care and will not get any treatment other than those the study doctor has prescribed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be recruited from cardiology sites reflecting a real-world population of ASCVD and HF patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.\n2. Age 18 years or above at the time of signing the informed consent.\n3. Presence of ASCVD (atherosclerotic cardiovascular disease) and/or HF (heart failure)\n4. Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).\n\nExclusion criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study.\n2. Current participation (i.e., signed informed consent) in any other interventional clinical study.\n3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).\n4. Clinical evidence, or suspicion of, active infection within the last 60 days.\n5. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation'}, 'identificationModule': {'nctId': 'NCT06122961', 'acronym': 'POSEIDON', 'briefTitle': 'Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Prevalence of Systemic Inflammation in Patients With Atherosclerotic Cardiovascular Disease and Heart Failure', 'orgStudyIdInfo': {'id': 'NN6018-7527'}, 'secondaryIdInfos': [{'id': 'U1111-1286-3420', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)', 'description': 'electronic case report form (eGFR) below 60 ml/min/1.73m\\^2', 'interventionNames': ['Other: No treatment given']}, {'label': 'ASCVD without CKD', 'description': 'eGFR greater than or equal to 60 ml/min/1.73m\\^2', 'interventionNames': ['Other: No treatment given']}, {'label': 'HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)', 'interventionNames': ['Other: No treatment given']}, {'label': 'Heart failure (HF) with reduced ejection fraction (HFrEF)', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given', 'armGroupLabels': ['ASCVD without CKD', 'Atherosclerotic cardiovascular disease (ASCVD) with chronic kidney disease (CKD)', 'HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)', 'Heart failure (HF) with reduced ejection fraction (HFrEF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Mission Cardiovascular Research Institute', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '75071', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Institute of Cardiology PA', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': 'B8001HXD', 'city': 'Bahía Blanca', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano Regional Sur', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'zip': '7540', 'city': 'Coronel Suárez', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Clínica Coronel Suarez', 'geoPoint': {'lat': -37.45859, 'lon': -61.93294}}, {'zip': 'B 1900AXI', 'city': 'La Plata', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de la Plata', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'B1824KAJ', 'city': 'Lanús Este', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Médico CIMEL', 'geoPoint': {'lat': -34.71416, 'lon': -58.37431}}, {'zip': 'C1093AAS', 'city': 'CABA', 'state': 'Buenos Aires, Argentina', 'country': 'Argentina', 'facility': 'Fundacion Favaloro'}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'INECO Neurociencias Oroño', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'B1704ETD', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'DIM Clinica Privada', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1878GEG', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Investigaciones Clinicas Quilmes SRL', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5003DCE', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Instituto Médico DAMIC', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'M5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Hospital Luis Lagomaggiore', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '2250', 'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Renal Research Gosford', 'geoPoint': {'lat': 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