Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT06101693
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With Suspected HFpEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1028}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-10', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure', 'timeFrame': '3 years', 'description': 'To determine the utility and diagnostic performance of alternative cut-offs for NT-proBNP or combinations of biomarkers (including novel biomarker solutions)- with clinical variables to identify HFpEF in obese patients with suspected heart failure. (New biomarkers will be used for observational purposes only.)'}], 'secondaryOutcomes': [{'measure': 'Prevalence of HF in patients with NT-proBNP<125ng/L', 'timeFrame': '3 years', 'description': 'To identify the prevalence of HF in patients with NT-proBNP \\<125 ng/L with and without obesity, and suspected HF.'}, {'measure': 'Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.', 'timeFrame': '3 years', 'description': 'To determine the utility and diagnostic performance of alternative cut-offs for NT-proBNP or combinations of biomarkers (including novel biomarker solutions) with clinical variables to identify HFpEF in patients (with and without obesity) and suspected HF.'}, {'measure': 'Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).', 'timeFrame': '3 years', 'description': 'To determine the utility and diagnostic performance of novel biomarkers, adjusted N-terminal pro-B-type natriuretic peptide (NT-proBNP) cut-offs or combinations of biomarkers with clinical variables in patients with suspected HF (HFpEF, HFmrEF, HFrEF). (New biomarkers will be used for observational purposes only.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Obesity', 'Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '34447992', 'type': 'BACKGROUND', 'citation': 'McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.'}, {'pmid': '25156856', 'type': 'BACKGROUND', 'citation': 'Madamanchi C, Alhosaini H, Sumida A, Runge MS. Obesity and natriuretic peptides, BNP and NT-proBNP: mechanisms and diagnostic implications for heart failure. Int J Cardiol. 2014 Oct 20;176(3):611-7. doi: 10.1016/j.ijcard.2014.08.007. Epub 2014 Aug 9.'}, {'pmid': '28381470', 'type': 'BACKGROUND', 'citation': 'Obokata M, Reddy YNV, Pislaru SV, Melenovsky V, Borlaug BA. Evidence Supporting the Existence of a Distinct Obese Phenotype of Heart Failure With Preserved Ejection Fraction. Circulation. 2017 Jul 4;136(1):6-19. doi: 10.1161/CIRCULATIONAHA.116.026807. Epub 2017 Apr 5.'}, {'pmid': '32750299', 'type': 'BACKGROUND', 'citation': 'Vaishnav J, Chasler JE, Lee YJ, Ndumele CE, Hu JR, Schulman SP, Russell SD, Sharma K. Highest Obesity Category Associated With Largest Decrease in N-Terminal Pro-B-Type Natriuretic Peptide in Patients Hospitalized With Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2020 Aug 4;9(15):e015738. doi: 10.1161/JAHA.119.015738. Epub 2020 Jul 30.'}, {'pmid': '29345112', 'type': 'BACKGROUND', 'citation': 'Buckley LF, Canada JM, Del Buono MG, Carbone S, Trankle CR, Billingsley H, Kadariya D, Arena R, Van Tassell BW, Abbate A. Low NT-proBNP levels in overweight and obese patients do not rule out a diagnosis of heart failure with preserved ejection fraction. ESC Heart Fail. 2018 Apr;5(2):372-378. doi: 10.1002/ehf2.12235. Epub 2018 Jan 18.'}, {'pmid': '26940695', 'type': 'BACKGROUND', 'citation': 'Meijers WC, Hoekstra T, Jaarsma T, van Veldhuisen DJ, de Boer RA. Patients with heart failure with preserved ejection fraction and low levels of natriuretic peptides. Neth Heart J. 2016 Apr;24(4):287-95. doi: 10.1007/s12471-016-0816-8.'}, {'pmid': '29792299', 'type': 'BACKGROUND', 'citation': 'Reddy YNV, Carter RE, Obokata M, Redfield MM, Borlaug BA. A Simple, Evidence-Based Approach to Help Guide Diagnosis of Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):861-870. doi: 10.1161/CIRCULATIONAHA.118.034646.'}, {'pmid': '32133741', 'type': 'BACKGROUND', 'citation': 'Pieske B, Tschope C, de Boer RA, Fraser AG, Anker SD, Donal E, Edelmann F, Fu M, Guazzi M, Lam CSP, Lancellotti P, Melenovsky V, Morris DA, Nagel E, Pieske-Kraigher E, Ponikowski P, Solomon SD, Vasan RS, Rutten FH, Voors AA, Ruschitzka F, Paulus WJ, Seferovic P, Filippatos G. How to diagnose heart failure with preserved ejection fraction: the HFA-PEFF diagnostic algorithm: a consensus recommendation from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). Eur J Heart Fail. 2020 Mar;22(3):391-412. doi: 10.1002/ejhf.1741. Epub 2020 Mar 5.'}, {'pmid': '33012125', 'type': 'BACKGROUND', 'citation': 'Sanders-van Wijk S, Barandiaran Aizpurua A, Brunner-La Rocca HP, Henkens MTHM, Weerts J, Knackstedt C, Uszko-Lencer N, Heymans S, van Empel V. The HFA-PEFF and H2 FPEF scores largely disagree in classifying patients with suspected heart failure with preserved ejection fraction. Eur J Heart Fail. 2021 May;23(5):838-840. doi: 10.1002/ejhf.2019. Epub 2020 Nov 2. No abstract available.'}, {'pmid': '35762650', 'type': 'BACKGROUND', 'citation': 'Popescu BA, Beladan CC, Nagueh SF, Smiseth OA. How to assess left ventricular filling pressures by echocardiography in clinical practice. Eur Heart J Cardiovasc Imaging. 2022 Aug 22;23(9):1127-1129. doi: 10.1093/ehjci/jeac123. No abstract available.'}, {'pmid': '35775383', 'type': 'BACKGROUND', 'citation': 'Guazzi M, Wilhelm M, Halle M, Van Craenenbroeck E, Kemps H, de Boer RA, Coats AJS, Lund L, Mancini D, Borlaug B, Filippatos G, Pieske B. Exercise testing in heart failure with preserved ejection fraction: an appraisal through diagnosis, pathophysiology and therapy - A clinical consensus statement of the Heart Failure Association and European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Heart Fail. 2022 Aug;24(8):1327-1345. doi: 10.1002/ejhf.2601. Epub 2022 Jul 31.'}, {'pmid': '27880640', 'type': 'BACKGROUND', 'citation': 'Lancellotti P, Pellikka PA, Budts W, Chaudhry FA, Donal E, Dulgheru R, Edvardsen T, Garbi M, Ha JW, Kane GC, Kreeger J, Mertens L, Pibarot P, Picano E, Ryan T, Tsutsui JM, Varga A. The clinical use of stress echocardiography in non-ischaemic heart disease: recommendations from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1191-1229. doi: 10.1093/ehjci/jew190.'}, {'pmid': '35830183', 'type': 'BACKGROUND', 'citation': 'Reddy YNV, Kaye DM, Handoko ML, van de Bovenkamp AA, Tedford RJ, Keck C, Andersen MJ, Sharma K, Trivedi RK, Carter RE, Obokata M, Verbrugge FH, Redfield MM, Borlaug BA. Diagnosis of Heart Failure With Preserved Ejection Fraction Among Patients With Unexplained Dyspnea. JAMA Cardiol. 2022 Sep 1;7(9):891-899. doi: 10.1001/jamacardio.2022.1916.'}]}, 'descriptionModule': {'briefSummary': 'NT-proBNP does not adequately identify HF(pEF) in people with suspected HF at low levels, particularly in patients with obesity. This study will investigate:\n\n1. alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity\n2. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.\n3. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \\<125 ng/L\n4. the prevalence of HF in people with suspected HF and low NT-proBNP \\<125 ng/L)', 'detailedDescription': 'This will be a prospective observational, non-randomised study of patients in primary care with suspected HF.\n\nDetection of HFpEF in people without obesity is well-served by NT-proBNP. In contrast, NT-proBNP does not perform well when used to detect HFpEF in populations with obesity. There is increasing evidence that some people with low levels of NT-proBNP can have HF. As many as 50% of people with obesity and HFpEF (detected by elevated filling pressures) have NT-proBNP \\<125 ng/L. Some patients with HFpEF who are not obese can also have low natriuretic peptides levels.\n\nDelayed diagnosis can lead to adverse outcomes for patients, in particular presentation acutely to secondary care. In addition to this, some patients with HFpEF who are not obese can also have low natriuretic peptides levels.\n\nPatients with NTproBNP levels performed in the community for stable symptoms of suspected heart failure will be invited to participate.\n\nAssessments in this study will include clinical history and examination, patient-reported outcome measures, electrocardiography, echocardiography and biomarker (blood and urine) analysis. Heart failure diagnostic scores and clinical evaluation by heart failure experts will be used to make a clinical diagnosis of heart failure, and to correlate this with levels of plasma and urine biomarkers, both established and novel.\n\nPatients will be followed up passively (for a minimum of 10 years) using record linkage for subsequent hospitalisations or deaths.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with NT-proBNP levels taken in primary care to evaluate for suspected heart failure will be invited to participate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 18 years\n* NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure\n\nExclusion Criteria:\n\n* Unable to consent to inclusion in study due to significant cognitive impairment\n* Geographical/ social reasons preventing attending study centre\n* Unable to complete study assessments\n* Patients presenting with acute HF or a previous diagnosis of HF'}, 'identificationModule': {'nctId': 'NCT06101693', 'acronym': 'BIOPEF', 'briefTitle': 'Biomarkers in Patients With Suspected HFpEF', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'GN23CA025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary care', 'description': 'Expected recruitment of 400 patients (50-60% expected prevalence of obesity, according to population study)', 'interventionNames': ['Diagnostic Test: Plasma biomarker levels']}, {'label': 'Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary care', 'description': 'Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)', 'interventionNames': ['Diagnostic Test: Plasma biomarker levels']}, {'label': 'Patients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care', 'description': 'Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)', 'interventionNames': ['Diagnostic Test: Plasma biomarker levels']}], 'interventions': [{'name': 'Plasma biomarker levels', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Rest echocardiography', 'Diastolic stress echocardiography'], 'description': 'This study will investigate the diagnostic utility and performance of:\n\n1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom\n2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.\n3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \\<125 ng/L\n4. The prevalence of HF in people with suspected HF and low NT-proBNP \\<125 ng/L).\n\nThe diagnosis of heart failure will be determined according to international guidelines, when there are symptoms and/or signs of HF in association with "objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures". Non-invasive testing with rest and diastolic stress echocardiography will be used to evaluate for evidence of raised filling pressures, in order to make the study procedures applicable to usual clinical practice.', 'armGroupLabels': ['Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary care', 'Patients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary care', 'Patients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G128TA', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Mark Petrie, MBChB', 'role': 'CONTACT', 'email': 'mark.petrie@glasgow.ac.uk', 'phone': '0141 330 2427'}, {'name': 'Alice Brennan, MBChBAO', 'role': 'CONTACT', 'email': 'alice.brennan@glasgow.ac.uk'}], 'facility': 'Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ross Campbell, MBChB', 'role': 'CONTACT', 'email': 'ross.campbell@glasgow.ac.uk', 'phone': '01413302418'}, {'name': 'Alice Brennan, MBChBAO', 'role': 'CONTACT', 'email': 'alice.brennan@glasgow.ac.uk'}], 'facility': 'New Victoria Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ross Campbell, MBChB', 'role': 'CONTACT', 'email': 'ross.campbell@glasgow.ac.uk', 'phone': '01413302418'}, {'name': 'Alice Brennan, MBChBAO', 'role': 'CONTACT', 'email': 'alice.brennan@glasgow.ac.uk'}], 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Ross Campbell, MBChB', 'role': 'CONTACT', 'email': 'ross.campbell@glasgow.ac.uk', 'phone': '01413302418'}, {'name': 'Mark Petrie, MBChB', 'role': 'CONTACT', 'email': 'mark.petrie@glasgow.ac.uk', 'phone': '0141 330 2427'}], 'overallOfficials': [{'name': 'Ross Campbell, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Glasgow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}