Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-31 @ 6:27 PM
Study NCT ID:
NCT04864795
Status:
COMPLETED
Last Update Posted:
2024-11-04
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006947', 'term': 'Hyperkalemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2636}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients by RAASi optimisation', 'timeFrame': 'at 6-months intervals', 'description': 'overall'}, {'measure': 'Percentage of patients by RAASi dose modification following hyperkalaemic episodes', 'timeFrame': 'at 6-month intervals after a hyperkalaemic episode', 'description': 'RAASi'}, {'measure': 'Comparison of percentage of patients with RAASi treatment optimisation between patiromer treated and untreated patients following hyperkalaemic', 'timeFrame': 'at 6-months following enrolment', 'description': 'episodes'}], 'secondaryOutcomes': [{'measure': 'Occurrence and incidence of hyperkalaemia events by RAASi treatment optimisation', 'timeFrame': 'at 6-months following enrolment', 'description': 'RAASi'}, {'measure': 'Description of physician provided reasons for treatment decisions at initiation or modification/discontinuation of RAASi treatment', 'timeFrame': 'up to 6 months following enrolment', 'description': 'RAASi'}, {'measure': 'Description and change of disease status measured by patient reported outcome (PRO) by RAASi treatment optimisation', 'timeFrame': 'at enrolment and at approximately 6-months intervals', 'description': 'Kansas City Cardiomyopathy Questionnaire (KCCQ)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Hyperkalemia']}, 'referencesModule': {'references': [{'pmid': '40788620', 'type': 'DERIVED', 'citation': 'Greene SJ, Sauer AJ, Bohm M, Bozkurt B, Butler J, Cleland JGF, Coats AJS, Desai NR, Grobbee DE, Kelepouris E, Pinto F, Rosano G, Donachie V, Fabien S, Waechter S, Crespo-Leiro MG, Hulsmann M, Kempf T, Pfister O, Pouleur AC, Saxena M, Schulz M, Volterrani M, Anker SD, Kosiborod MN. Management of patients with heart failure at high risk of hyperkalaemia: The CARE-HK in HF registry. Eur J Heart Fail. 2025 Aug 11. doi: 10.1002/ejhf.3800. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients. For the purpose of this study, adherence to guidelines is defined as adherence to RAASi treatment recommendations, according to the AHA/ACC and ESC guidelines. Objectives relating to patiromer effectiveness will only be evaluated if a sufficient number of patients are available.\n\nThe study aims to evaluate in patients at high risk of hyperkalaemia; patients treated with ACEi/ARB/ARNi, and either treated with or candidates for treatment with MRA.', 'detailedDescription': 'The study will have an enrolment period of approximately 24 months, and each patient will be followed prospectively for at least 6 months. Each patient is expected to contribute to the study data collection until study end or until premature discontinuation, whichever occurs first (i.e., due to death, withdrawal of consent, or lost to follow-up).\n\nAt enrolment (informed consent signed by patient), relevant patient data will be retrospectively extracted from medical records for the 24 months prior to enrolment or since the time of HF diagnosis.\n\nThere are no visits or procedures associated with the study, patients will follow routine clinical care, which may include in-person and/or virtual visits. The study protocol does not recommend the use of any specific treatments and no study medication is provided as part of participation. The nature and heterogeneity of HF means patients will be treated with different treatments over the course of the study, and at the discretion of their treating physician.\n\nPatient data will be collected from patient records and/or during a routine clinical visit and will be entered into the electronic Case Report Form (eCRF) via an electronic data capture (EDC) system. This will include treatments prescribed, routine assessments and measurements (e.g., laboratory parameters) collected at routine clinical visits, as well as hospitalisations and other relevant patient data. Protocol version 3.0, 19-Jul-2023'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'To the extent possible, representative sites (e.g., cardiologists and nephrologists) reflective of the treatment patterns within each country will be recruited. All patients treated for chronic HF during the enrolment period will be assessed for eligibility, and all eligible patients will be consecutively proposed to enrol in the study as they present for a routine clinical visit (in-person or virtual visits) in order to avoid potential selection bias.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult aged ≥18 years at enrolment.\n2. Patient diagnosed with chronic HF ≥3 months prior to signature of informed consent.\n3. Patient has at least 1 record of LVEF documented in patient medical record in the 24 months prior to signature of informed consent. NOTE: If the proportion of patients with HFpEF exceeds 20% of the target sample size, enrolment of patients with an LVEF ≥50% may be capped.\n4. Patient treated with ACEi/ARB/ARNi at enrolment.\n5. Patient treated with or a candidate for treatment with MRA per a relevant treatment guideline (e.g., HF, CKD, resistant hypertension) at enrolment.\n6. Patient at increased risk of hyperkalaemia due to one or more of the following:\n\n 1. Current hyperkalaemia (sK+ \\>5.0 mEq/l) at enrolment\n 2. Record of documented hyperkalaemia (sK+ \\>5.0 mEq/l) in the 24 months prior to signature of informed consent\n 3. eGFR \\<45 ml/min/1.73 m2, or CKD Stage ≥3b.\n7. Patient judged by the Investigator to have sufficient cognitive ability to participate.\n8. Signed informed consent provided\n\nExclusion Criteria:\n\n1. Patient on renal replacement therapy or mechanical circulatory support.\n2. Disease other than HF with expected survival \\<1 year.\n3. Patient is participating in, or being screened for, an interventional trial, with the exception of interventional trials relating to SARS-CoV-2.\n4. Patient already found to be intolerant to MRA for reasons other than hyperkalaemia or renal impairment.'}, 'identificationModule': {'nctId': 'NCT04864795', 'acronym': 'CARE-HK', 'briefTitle': 'Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia (CARE-HK in HF Registry)', 'orgStudyIdInfo': {'id': 'HQ-NIS-CHF-07.2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single Cohort', 'description': 'Patient data will be collected from patient records and/or during a routine clinical visit. This will include treatments prescribed, routine assessments and measurements collected at routine clinical visits, as well as hospitalisations and other relevant patient data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Sulpizio Cardiovascular Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Amicis Research Center', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '33425', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Bethesda Hospital East', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33013', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Inpatient Research Clinic, LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33777', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Consultants', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'D&H National Research Centers', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102-8143', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Southwest Florida Research, LLC', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Peace River Cardiovascular Center', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '32695', 'city': 'Safety Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular and Interventional Consultants', 'geoPoint': {'lat': 27.99085, 'lon': -82.69316}}, {'zip': '32792', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cardiology P.A', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'IACT Health', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '31024', 'city': 'Eatonton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cardiology Care Clinics', 'geoPoint': {'lat': 33.3268, 'lon': -83.3885}}, {'zip': '30024', 'city': 'Johns Creek', 'state': 'Georgia', 'country': 'United States', 'facility': 'NSC Research', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}, {'zip': '60429-2196', 'city': 'Hazel Crest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Medical Research, LLC', 'geoPoint': {'lat': 41.5717, 'lon': -87.69449}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Cardiovascular Consultants, Ltd.', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cardiovascular Medicine, P.C.', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '42701', 'city': 'Elizabethtown', 'state': 'Kentucky', 'country': 'United States', 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'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Health - Temple', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '77901', 'city': 'Victoria', 'state': 'Texas', 'country': 'United States', 'facility': 'Victoria Heart & Vascular Center', 'geoPoint': {'lat': 28.80527, 'lon': -97.0036}}, {'zip': '23116', 'city': 'Mechanicsville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond Cardiology Associates', 'geoPoint': {'lat': 37.60876, 'lon': -77.37331}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'William S. 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