Heart FailureBIOPEFNCT06101693
Biomarkers in Patients With Suspected HFpEF
An observational study of Heart Failure and Obesity, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
Trial summary
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: 1. alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Obesity, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Plasma biomarker levels
- How many people
- 1,028 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 2 Feb 2023to 29 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NT-proBNP levels taken in primary care to evaluate for suspected heart failure will be invited to participate.
Who may be able to join
- Written informed consent
- Age ≥ 18 years
- NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure
Who cannot join
- Unable to consent to inclusion in study due to significant cognitive impairment
- Geographical/ social reasons preventing attending study centre
- Unable to complete study assessments
- Patients presenting with acute HF or a previous diagnosis of HF
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Glasgow Royal Infirmary
Glasgow, G128TA
Mark Petrie, MBChB, 0141 330 2427, mark.petrie@glasgow.ac.uk
Alice Brennan, MBChBAO, alice.brennan@glasgow.ac.uk
- Recruiting
New Victoria Hospital
Glasgow, G51 4TF
Ross Campbell, MBChB, 01413302418, ross.campbell@glasgow.ac.uk
Alice Brennan, MBChBAO, alice.brennan@glasgow.ac.uk
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Ross Campbell, MBChB, 01413302418, ross.campbell@glasgow.ac.uk
Alice Brennan, MBChBAO, alice.brennan@glasgow.ac.uk
About this study
Official title: Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction
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:
- alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP <125 ng/L
- the prevalence of HF in people with suspected HF and low NT-proBNP <125 ng/L)
Read the detailed description
This will be a prospective observational, non-randomised study of patients in primary care with suspected HF.
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.
- Being tested
- Plasma biomarker levels
- Medical subject headings
- Heart Failure, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma biomarker levelsDiagnostic test
Also called Rest echocardiography, Diastolic stress echocardiography
This study will investigate the diagnostic utility and performance of:
- Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
- Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
- Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP <125 ng/L
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Plasma biomarker levels | |
| 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) Receives: Diagnostic Test: Plasma biomarker levels | |
| 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) Receives: Diagnostic Test: Plasma biomarker levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure
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.)
Measured: 3 years
Secondary outcomes (3)
Prevalence of HF in patients with NT-proBNP<125ng/L
To identify the prevalence of HF in patients with NT-proBNP <125 ng/L with and without obesity, and suspected HF.
Measured: 3 years
Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.
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.
Measured: 3 years
Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).
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.)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start2 Feb 2023
- Primary completion29 Sep 2025 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,028 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Ross Campbell, MBChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101693
- Sponsor's protocol ID
- GN23CA025
- Acronym
- BIOPEF
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34447992Madamanchi 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.
PubMed 25156856Obokata 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.
PubMed 28381470Vaishnav 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.
PubMed 32750299Buckley 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.
PubMed 29345112Meijers 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.
PubMed 26940695Reddy 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.
PubMed 29792299Pieske 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.
PubMed 32133741Sanders-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.
PubMed 33012125Popescu 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.
PubMed 35762650Guazzi 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.
PubMed 35775383Lancellotti 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.
PubMed 27880640Reddy 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.
PubMed 35830183
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06101693
- Acronym / sponsor ID
- BIOPEF / GN23CA025
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,028 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Roche Diagnostics GmbH
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 29 Sep 2025 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP <125 ng/L
- the prevalence of HF in people with suspected HF and low NT-proBNP <125 ng/L)
Detailed description
This will be a prospective observational, non-randomised study of patients in primary care with suspected HF.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary care | – | Diagnostic Test: Plasma biomarker levelsExpected recruitment of 400 patients (50-60% expected prevalence of obesity, according to population study) |
| Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary care | – | Diagnostic Test: Plasma biomarker levelsExpected recruitment of 400 patients (50% expected prevalence of obesity, according to population study) |
| Patients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care | – | Diagnostic Test: Plasma biomarker levelsExpected recruitment of 400 patients (50% expected prevalence of obesity, according to population study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NT-proBNP levels taken in primary care to evaluate for suspected heart failure will be invited to participate.
Key inclusion criteria (3 listed)
- Written informed consent
- Age ≥ 18 years
- NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure
Key exclusion criteria (4 listed)
- Unable to consent to inclusion in study due to significant cognitive impairment
- Geographical/ social reasons preventing attending study centre
- Unable to complete study assessments
- Patients presenting with acute HF or a previous diagnosis of HF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma biomarker levelsAlso: Rest echocardiography, Diastolic stress echocardiographyThis 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. | Diagnostic test | 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 |
Primary outcome
Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure
Time frame: 3 years
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.)
3 secondary outcomes
Prevalence of HF in patients with NT-proBNP<125ng/L
Time frame: 3 years
Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.
Time frame: 3 years
Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 25156856Madamanchi 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.
- Background: PubMed 28381470Obokata 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.
- Background: PubMed 32750299Vaishnav 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.
- Background: PubMed 29345112Buckley 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.
- Background: PubMed 26940695Meijers 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.
- Background: PubMed 29792299Reddy 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.
- Background: PubMed 32133741Pieske 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.
- Background: PubMed 33012125Sanders-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.
- Background: PubMed 35762650Popescu 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.
- Background: PubMed 35775383Guazzi 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.
- Background: PubMed 27880640Lancellotti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Campbell, MBChB principal investigator
University of Glasgow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Obesity, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Campbell, MBChB (01413302418, ross.campbell@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101693, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.