Retrospective Observational Analysis of a Cohort With Heart Failure With Preserved Ejection Fraction

NCT04233086 | Completed

• 1 other identifier: 262060
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure with preserved ejection fraction (HFpEF) is a complex condition with various causes that is not yet fully understood. Most significantly there is no single method of diagnosing or treating the condition. Recently a novel non-invasive diagnostic criterion to predict the likelihood of HFpEF was proposed called H2FPEF. The main limitation of this study was the use of a single centre population from the Mayo clinic in Rochester, US. Another limitation is that the H2FPEF diagnostic criterion consists of common and often co-existing conditions which could as a result overestimate HFpEF probability. The aim of the investigators is to retrospectively test the H2FPEF criteria on the population at Queen Alexandra Hospital (QAH) in Portsmouth, which is of a lower socio-economic status and greater ethnic diversity. Implications of the proposed project if H2FPEF is proved to be generalizable to the study population is that it can be used within the Trust and rolled out to others. This would allow diagnosis to be made quicker and more cost effectively using echocardiography and without the need for invasive cardiac catheterisation. On the other hand if H2FPEF is found not to be applicable to the population then further research would be required to find the ideal diagnostic tool.

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• To assess the predictive and diagnostic accuracy of H2FPEF at predicting HFpEF on our patient population

  Predictive accuracy calculated with logistic regression and diagnostic accuracy with specificity and sensitivity calculations

  February - April 2020

Secondary Outcomes (2)

• Follow-up of patient outcomes - Hospital admissions

  February - April 2020

• Follow-up of patient outcomes - Change in treatment

  February - April 2020

Study Arms (1)

Patients referred through the BNP pathway

Patients throughout 2016 referred through the BNP pathway at Queen Alexandra Hospital will retrospectively be assessed for Reddy et al (2018) H2FPEF score.

Other: No intervention, observational only

Interventions

No intervention, observational only OTHER

No intervention, observational only

Patients referred through the BNP pathway

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be patients who have attended heart failure clinics at QAH between 01/01/2016 - 31/12/2016. Eligibility will be met by the inclusion and exclusion criteria.

You may qualify if:

• Age 18-95yrs inclusive
• Currently or previously attended a heart failure clinic with a cardiology consultant at QAH
• Had an echocardiogram, ECG, BNP blood biomarker test in addition to a routine clinical evaluation (including age, weight and number of hypertensive medications) during January 1st 2016 - December 31st 2016.

You may not qualify if:

• Known structural heart disease
• Significant heart valve disease (greater than mild stenosis, greater than moderate regurgitation)
• Pulmonary arterial hypertension
• Constrictive pericarditis
• Pre-existing cardiomyopathy
• Heart transplantation

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Portsmouth University Hospital

Portsmouth, Hampshire, PO63LY, United Kingdom

Location

Related Publications (10)

• Borlaug BA, Paulus WJ. Heart failure with preserved ejection fraction: pathophysiology, diagnosis, and treatment. Eur Heart J. 2011 Mar;32(6):670-9. doi: 10.1093/eurheartj/ehq426. Epub 2010 Dec 7.

  PMID: 21138935 BACKGROUND

• Telles F, Marwick TH. Imaging and Management of Heart Failure and Preserved Ejection Fraction. Curr Treat Options Cardiovasc Med. 2018 Sep 27;20(11):90. doi: 10.1007/s11936-018-0689-9.

  PMID: 30259312 BACKGROUND

• Borlaug BA. The pathophysiology of heart failure with preserved ejection fraction. Nat Rev Cardiol. 2014 Sep;11(9):507-15. doi: 10.1038/nrcardio.2014.83. Epub 2014 Jun 24.

  PMID: 24958077 BACKGROUND

• Ferrari R, Bohm M, Cleland JG, Paulus WJ, Pieske B, Rapezzi C, Tavazzi L. Heart failure with preserved ejection fraction: uncertainties and dilemmas. Eur J Heart Fail. 2015 Jul;17(7):665-71. doi: 10.1002/ejhf.304. Epub 2015 Jun 16.

  PMID: 26079097 BACKGROUND

• Harper AR, Patel HC, Lyon AR. Heart failure with preserved ejection fraction. Clin Med (Lond). 2018 Apr 1;18(Suppl 2):s24-s29. doi: 10.7861/clinmedicine.18-2-s24.

  PMID: 29700089 BACKGROUND

• Lekavich CL, Barksdale DJ, Neelon V, Wu JR. Heart failure preserved ejection fraction (HFpEF): an integrated and strategic review. Heart Fail Rev. 2015 Nov;20(6):643-53. doi: 10.1007/s10741-015-9506-7.

  PMID: 26404098 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• 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: 29792299 RESULT

• Andersen OS, Smiseth OA, Dokainish H, Abudiab MM, Schutt RC, Kumar A, Sato K, Harb S, Gude E, Remme EW, Andreassen AK, Ha JW, Xu J, Klein AL, Nagueh SF. Estimating Left Ventricular Filling Pressure by Echocardiography. J Am Coll Cardiol. 2017 Apr 18;69(15):1937-1948. doi: 10.1016/j.jacc.2017.01.058.

  PMID: 28408024 RESULT

• Lancellotti P, Galderisi M, Edvardsen T, Donal E, Goliasch G, Cardim N, Magne J, Laginha S, Hagendorff A, Haland TF, Aaberge L, Martinez C, Rapacciuolo A, Santoro C, Ilardi F, Postolache A, Dulgheru R, Mateescu AD, Beladan CC, Deleanu D, Marchetta S, Auffret V, Schwammenthal E, Habib G, Popescu BA. Echo-Doppler estimation of left ventricular filling pressure: results of the multicentre EACVI Euro-Filling study. Eur Heart J Cardiovasc Imaging. 2017 Sep 1;18(9):961-968. doi: 10.1093/ehjci/jex067.

  PMID: 28444160 RESULT

Study Officials

• Kaushik Guha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 18, 2020
• Study Start: February 3, 2020
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)