NCT06101693

Brief 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. 1.alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity
  2. 2.novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
  3. 3.novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L
  4. 4.the prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,028

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 2, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2026

Expected
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

October 20, 2023

Last Update Submit

February 10, 2024

Conditions

Heart FailureObesityHeart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • 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.)

    3 years

Secondary Outcomes (3)

  • Prevalence of HF in patients with NT-proBNP<125ng/L

    3 years

  • Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.

    3 years

  • Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).

    3 years

Study Arms (3)

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)

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)

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)

Diagnostic Test: Plasma biomarker levels

Interventions

Plasma biomarker levelsDIAGNOSTIC_TEST

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.

Also known as: Rest echocardiography, Diastolic stress echocardiography
Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary carePatients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary carePatients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with NT-proBNP levels taken in primary care to evaluate for suspected heart failure will be invited to participate.

You may qualify if:

  • Written informed consent
  • Age ≥ 18 years
  • NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure

You may not qualify if:

  • Geographical/ social reasons preventing attending study centre
  • Unable to complete study assessments
  • Patients presenting with acute HF or a previous diagnosis of HF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Glasgow Royal Infirmary

Glasgow, G128TA, United Kingdom

RECRUITING

New Victoria Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

RECRUITING

Related Publications (13)

  • 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: 34447992BACKGROUND

  • 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: 25156856BACKGROUND

  • 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: 28381470BACKGROUND

  • 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: 32750299BACKGROUND

  • 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: 29345112BACKGROUND

  • 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: 26940695BACKGROUND

  • 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: 29792299BACKGROUND

  • 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: 32133741BACKGROUND

  • 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: 33012125BACKGROUND

  • 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: 35762650BACKGROUND

  • 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: 35775383BACKGROUND

  • 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: 27880640BACKGROUND

  • 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.

    PMID: 35830183BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Plasma RNA

MeSH Terms

Conditions

Heart FailureObesity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ross Campbell, MBChB

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ross Campbell, MBChB

CONTACT

01413302418ross.campbell@glasgow.ac.uk

Mark Petrie, MBChB

CONTACT

0141 330 2427mark.petrie@glasgow.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

February 2, 2023

Primary Completion

September 29, 2025

Study Completion (Estimated)

September 29, 2026

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

GB(3)