Study Results
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Basic Information
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RECRUITING
1028 participants
OBSERVATIONAL
2023-02-02
2026-09-29
Brief Summary
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1. alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity
2. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
3. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
4. the prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L)
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Detailed Description
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Detection 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.
Delayed 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.
Patients with NTproBNP levels performed in the community for stable symptoms of suspected heart failure will be invited to participate.
Assessments 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.
Patients will be followed up passively (for a minimum of 10 years) using record linkage for subsequent hospitalisations or deaths.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary care
Expected recruitment of 400 patients (50-60% expected prevalence of obesity, according to population study)
Plasma biomarker levels
This study will investigate the diagnostic utility and performance of:
1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
4. The prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L).
The 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.
Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary care
Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)
Plasma biomarker levels
This study will investigate the diagnostic utility and performance of:
1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
4. The prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L).
The 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.
Patients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care
Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)
Plasma biomarker levels
This study will investigate the diagnostic utility and performance of:
1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
4. The prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L).
The 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.
Interventions
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Plasma biomarker levels
This study will investigate the diagnostic utility and performance of:
1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
4. The prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L).
The 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure
Exclusion Criteria
* Geographical/ social reasons preventing attending study centre
* Unable to complete study assessments
* Patients presenting with acute HF or a previous diagnosis of HF
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Roche Diagnostics GmbH
INDUSTRY
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Ross Campbell, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Glasgow Royal Infirmary
Glasgow, , United Kingdom
New Victoria Hospital
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GN23CA025
Identifier Type: -
Identifier Source: org_study_id
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