Decision Support System for Diagnosis and Progression of Heart Failure

NCT06377319 | Not Yet Recruiting

• 1 other identifier: 101080905
• Study Type: observational
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to develop, validate and implement the first artificial intelligence (AI)-based, Decision Support System (DSS) for assessing and predicting the risk of HF development, its early diagnosis and progression. STRATIFYHF will integrate 1) patient-specific data i.e. demographic, clinical, genetic, lifestyle and socio-economic, 2) an AI-based digital patient library and AI-driven algorithms for risk stratification, early diagnosis, and disease progression in HF, and 3) a highly innovative multifunctional AI-based DSS and mobile application for informing a patient-centred, personalised, prevention and treatment strategies for HF.

Conditions

Heart Failure

Keywords

heart failure; risk prediction; diagnosis; progression; decision support system

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the DSS

  Collection of prospective data for the diagnostic accuracy (i.e., sensitivity and specificity) of the DSS to predict risk of developing HF within 12 months.

  12 months

Secondary Outcomes (1)

• Demographic and clinical predictors of risk, diagnosis, and progression of heart failure.

  12 months

Study Arms (2)

Patients at risk of developing heart failure

Individuals at risk of developing HF ≥45 years of age sub-divided into two categories i.e., (i) patients with current or prior symptoms or signs of HF, but without structural, biomarker, or genetic markers of heart disease but have evidence of one of the following: hypertension, cardiovascular disease, type 2 diabetes mellitus, metabolic syndrome, known exposure to cardiotoxins and family history of cardiomyopathy and (ii) Patients with current or prior symptoms or signs of HF and have evidence of one of the following - structural heart disease (e.g. Left ventricular (LV) hypertrophy, chamber enlargement, wall motion abnormality, valvular disease), abnormal cardiac function (e.g., reduced LV or right ventricular systolic function, evidence of increased filling pressures or abnormal diastolic function), elevated natriuretic peptide or elevated cardiac troponin on exposure to a cardiotoxin. Willing to visit the clinical research facility and able to provide written informed consent.

Diagnostic Test: Cardiac Output Response to Stress (CORS) test

Patients diagnosed with heart failure

Patients with confirmed diagnosis of HF (heart failure reduced ejection fraction; heart failure mildly reduced ejection fraction; heart failure improved ejection fraction; and heart failure preserved ejection fraction) over the previous 24 months or hospitalisation due to HF ≥45 years of age; willingness to visit the clinical research facility and able to provide written informed consent.

Diagnostic Test: Cardiac Output Response to Stress (CORS) test

Interventions

Cardiac Output Response to Stress (CORS) test DIAGNOSTIC_TEST

Cardiac Output Response to Stress (CORS) is a novel, non-invasive, easy-to-use test developed by the Newcastle and Coventry Universities. CORS test measures heart function (cardiac output) at rest and in response to short step-exercise using validated electrical signal processing bioreactance technology, similar to an ECG.

Patients at risk of developing heart failure; Patients diagnosed with heart failure

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population would include men and women suspected with heart failure who have been referred to secondary care for specialist review and have attended a heart failure diagnostic clinic.

You may qualify if:

• Individuals at risk of developing HF ≥45 years of age sub-divided into two categories based on current definitions i.e.,
• (i) patients with current or prior symptoms or signs of HF, but without structural, biomarker, or genetic markers of heart disease but have evidence of one of the following: hypertension, cardiovascular disease, type 2 diabetes mellitus, metabolic syndrome, known exposure to cardiotoxins and family history of cardiomyopathy and
• (ii) Patients with current or prior symptoms or signs of HF and have evidence of one of the following - structural heart disease (e.g. Left ventricular (LV) hypertrophy, chamber enlargement, wall motion abnormality, valvular disease), abnormal cardiac function (e.g., reduced LV or right ventricular systolic function, evidence of increased filling pressures or abnormal diastolic function), elevated natriuretic peptide or elevated cardiac troponin on exposure to a cardiotoxin.
• All patients willing to visit the clinical research facility and able to provide written informed consent.
• Patients with confirmed diagnosis of HF (heart failure reduced ejection fraction; heart failure mildly reduced ejection fraction; heart failure improved ejection fraction; and heart failure preserved ejection fraction) over the previous 24 months or
• hospitalisation due to HF ≥45 years of age
• willing to visit the clinical research facility and able to provide written informed consent.

You may not qualify if:

• inability to provide verbal informed consent
• presenting with severe symptoms
• major co-morbidity or other alternative diagnoses (e.g., malignancy, severe respiratory disease, mental health problem); recent acute coronary syndrome (within 60 days)
• severe physical disability preventing independence
• scheduled or implanted pacemaker or cardio-defibrillator in the last 3 months
• severe renal insufficiency
• present or planned pregnancy
• life expectancy less than 12 months.

Sponsors & Collaborators

• Coventry University: lead
• Newcastle University: collaborator
• University of Cambridge: collaborator
• University of Novi Sad: collaborator
• University of Florence: collaborator
• University of Regensburg: collaborator
• Utrecht University, Utrecht, the Netherlands.: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator

Related Publications (15)

• Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.

  PMID: 29174292 BACKGROUND

• 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: 34447992 BACKGROUND

• Maggioni AP. Epidemiology of Heart Failure in Europe. Heart Fail Clin. 2015 Oct;11(4):625-35. doi: 10.1016/j.hfc.2015.07.015. Epub 2015 Aug 8.

  PMID: 26462102 BACKGROUND

• Roberts E, Ludman AJ, Dworzynski K, Al-Mohammad A, Cowie MR, McMurray JJ, Mant J; NICE Guideline Development Group for Acute Heart Failure. The diagnostic accuracy of the natriuretic peptides in heart failure: systematic review and diagnostic meta-analysis in the acute care setting. BMJ. 2015 Mar 4;350:h910. doi: 10.1136/bmj.h910.

  PMID: 25740799 BACKGROUND

• Bozkurt B, Coats A, Tsutsui H. Universal Definition and Classification of Heart Failure. J Card Fail. 2021 Feb 7:S1071-9164(21)00050-6. doi: 10.1016/j.cardfail.2021.01.022. Online ahead of print.

  PMID: 33662581 BACKGROUND

• Jakovljevic DG, Trenell MI, MacGowan GA. Bioimpedance and bioreactance methods for monitoring cardiac output. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):381-94. doi: 10.1016/j.bpa.2014.09.003. Epub 2014 Sep 23.

  PMID: 25480768 BACKGROUND

• Jones TW, Houghton D, Cassidy S, MacGowan GA, Trenell MI, Jakovljevic DG. Bioreactance is a reliable method for estimating cardiac output at rest and during exercise. Br J Anaesth. 2015 Sep;115(3):386-91. doi: 10.1093/bja/aeu560. Epub 2015 Feb 6.

  PMID: 25659999 BACKGROUND

• Jakovljevic DG, Moore S, Hallsworth K, Fattakhova G, Thoma C, Trenell MI. Comparison of cardiac output determined by bioimpedance and bioreactance methods at rest and during exercise. J Clin Monit Comput. 2012 Apr;26(2):63-8. doi: 10.1007/s10877-012-9334-4. Epub 2012 Jan 11.

  PMID: 22234400 BACKGROUND

• Okwose NC, Chowdhury S, Houghton D, Trenell MI, Eggett C, Bates M, MacGowan GA, Jakovljevic DG. Comparison of cardiac output estimates by bioreactance and inert gas rebreathing methods during cardiopulmonary exercise testing. Clin Physiol Funct Imaging. 2018 May;38(3):483-490. doi: 10.1111/cpf.12442. Epub 2017 Jun 2.

  PMID: 28574213 BACKGROUND

• Charman SJ, Okwose NC, Taylor CJ, Bailey K, Fuat A, Ristic A, Mant J, Deaton C, Seferovic PM, Coats AJS, Hobbs FDR, MacGowan GA, Jakovljevic DG. Feasibility of the cardiac output response to stress test in suspected heart failure patients. Fam Pract. 2022 Sep 24;39(5):805-812. doi: 10.1093/fampra/cmab184.

  PMID: 35083480 BACKGROUND

• Charman S, Okwose N, Maniatopoulos G, Graziadio S, Metzler T, Banks H, Vale L, MacGowan GA, Seferovic PM, Fuat A, Deaton C, Mant J, Hobbs RFD, Jakovljevic DG. Opportunities and challenges of a novel cardiac output response to stress (CORS) test to enhance diagnosis of heart failure in primary care: qualitative study. BMJ Open. 2019 Apr 14;9(4):e028122. doi: 10.1136/bmjopen-2018-028122.

  PMID: 30987993 BACKGROUND

• Krittanawong C, Johnson KW, Rosenson RS, Wang Z, Aydar M, Baber U, Min JK, Tang WHW, Halperin JL, Narayan SM. Deep learning for cardiovascular medicine: a practical primer. Eur Heart J. 2019 Jul 1;40(25):2058-2073. doi: 10.1093/eurheartj/ehz056.

  PMID: 30815669 BACKGROUND

• Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000 Oct;32(4):1008-15.

  PMID: 11095242 BACKGROUND

• National Clinical Guideline Centre (UK). Chronic Heart Failure: National Clinical Guideline for Diagnosis and Management in Primary and Secondary Care: Partial Update [Internet]. London: Royal College of Physicians (UK); 2010 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK65340/

  PMID: 22741186 BACKGROUND

• Charman SJ, Okwose NC, Groenewegen A, Del Franco A, Tafelmeier M, Preveden A, Garcia Sebastian C, Fuller AS, Sinclair D, Edwards D, Nelissen AP, Malitas P, Zisaki A, Darba J, Bosnic Z, Vracar P, Barlocco F, Fotiadis D, Banerjee P, MacGowan GA, Fernandez O, Zamorano J, Jimenez-Blanco Bravo M, Maier LS, Olivotto I, Rutten FH, Mant J, Velicki L, Seferovic PM, Filipovic N, Jakovljevic DG; STRATIFYHF investigators. Clinical validation of an artificial intelligence-based decision support system for diagnosis and risk stratification of heart failure (STRATIFYHF): a protocol for a prospective, multicentre longitudinal study. BMJ Open. 2025 Jan 7;15(1):e091793. doi: 10.1136/bmjopen-2024-091793.

  PMID: 39773784 DERIVED

MeSH Terms

Conditions

Heart Failure; Disease; Disease Progression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Djordje Jakovljevic

  Coventry University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Djordje Jakovljevic

CONTACT

07522694321; djordje.jakovljevic@coventry.ac.uk

Nduka Okwose

CONTACT

+447448930074; ad6707@coventry.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Months 0 to 24
• Access Criteria: Data sharing agreement already in place with all project partners