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

April 6, 2023 updated by: Portsmouth Hospitals NHS Trust

A Retrospective Observational Analysis of a Cohort With Heart Failure With Preserved Ejection Fraction From a BNP Pathway Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

HFpEF was previously characterised as 'diastolic dysfunction' but this terminology was changed as it was found that diastolic dysfunction was also seen in patients with 'systolic dysfunction'. Myocardial stiffness which leads to increased filling pressures is a common pathophysiologic attribute of HFpEF despite its multifactorial aetiology. Other common conditions associated with HFpEF include: atrial fibrillation (AF), chronotropic incompetence, pulmonary hypertension, right ventricular dysfunction and endothelial dysfunction; with common non-specific risk factors such as: age, gender, hypertension, obesity, diabetes, metabolic syndrome and renal failure. This complex heterogeneity of HFpEF which is not yet fully understood highlights the difficulty that clinicians have in being able to diagnose the condition.

Diagnosis of HFpEF is difficult and as of yet there is no test to confirm diagnosis, with current guidelines saying initial diagnosis should include the presence of typical signs and symptoms, an elevated B-type natriuretic peptide (BNP) (>35 pg/mL and/or N-Terminal pro-B-type Natriuretic Peptide [NT-proBNP] >125 pg/mL) and ejection fraction ≥50%. Echocardiography is the preferred method of assessing for HFpEF due to it being widely available, non-invasive, and able to provide immediate results. Recent studies comparing the use of echocardiography against 'gold standard' invasive cardiac catheterisation to assess cardiac filling pressures found echocardiography to be just as accurate and reliable. Implications of this research would be that patients could be assessed as outpatients by focus echocardiography rather than invasively in the cardiac catheterisation lab, which would improve patient experience, enhance patient outcomes and prove cost-effective for trusts.

In response a recently proposed non-invasive diagnostic criteria called H2FPEF which assesses patients based on body mass index (BMI), the number of hypertensive medications they take, presence of AF, pulmonary pressure, age and filling pressure. The advantage of the H2FPEF score is that it uses only non-invasive echocardiography data alongside routine clinical data making it easy to derive. However one key limitation of their study is the population they used was all from the Mayo clinic and so the generalisability of their results has not been tested for other populations, such as those of lower socioeconomic status like in Portsmouth. A further limitation is the parameters chosen to create H2FPEF are all relatively common morbidities and usually co-exist, making it likely that it will over diagnose HFpEF.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO63LY
        • Portsmouth University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No intervention, observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the predictive and diagnostic accuracy of H2FPEF at predicting HFpEF on our patient population
Time Frame: February - April 2020
Predictive accuracy calculated with logistic regression and diagnostic accuracy with specificity and sensitivity calculations
February - April 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up of patient outcomes - Hospital admissions
Time Frame: February - April 2020
To assess number of hospital admissions after one year for the study population.
February - April 2020
Follow-up of patient outcomes - Change in treatment
Time Frame: February - April 2020
To assess any changes in treatment after one year for the study population.
February - April 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portsmouth Hospitals NHS Trust

Collaborators

Manchester Metropolitan University

Investigators

  • Principal Investigator: Kaushik Guha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Actual)

April 3, 2020

Study Completion (Actual)

April 3, 2020

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No participant data will be shared under the Data Protection Act. Only overall results of the statistical analyses will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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