Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
NCT ID: NCT06386185
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2024-09-06
2026-12-01
Brief Summary
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The main questions it aims to answer are:
Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?
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Detailed Description
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PH can be caused by a number of different conditions and life expectancy varies with the underlying cause, ranging from months to years. For some subtypes of PH, effective treatments exist which can significantly improve life expectancy and quality of life. Accurate tools for the assessment of PH are therefore essential, so that we can better understand and predict life expectancy and so that life-saving medications can be started earlier.
Once doctors suspect that somebody has PH, they refer them to a specialist PH centre for assessment and a procedure called right heart catheterisation (RHC), which will confirm the diagnosis. However, evidence for the suspicion of PH is frequently overlooked, leading to an average delay to diagnosis from onset of symptoms of two years. This late presentation negatively impacts survival for these patients and prevents them promptly starting the effective treatments which are available.
An electrocardiogram (ECG) is a recording of the heart's electrical signals, printed in waveforms. It is a painless, low-cost, and readily-available test used in PH assessment.
Echocardiography (echo) is a quick, safe and well-tolerated test often requested to investigate breathless patients and can provide useful information about the suspicion of PH. Echo has however been shown to lack accuracy in milder forms of the disease. It has been hypothesised that subtle markers of right ventricular function by echo, such as free wall strain (RVFWS) begin to deteriorate before the more established findings.
A large, cross-population study of ECG features and echo markers such as RVFWS both in isolation and in combination, in patients referred for PH assessment may help identify these markers, and improve detection of the disease.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Diagnostic Test
Patients referred for initial PH investigations, who underwent ECG and echo screening prior to RHC.
Electrocardiogram
Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart
Transthoracic echocardiogram
Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound
Right heart catheter
Minimally invasive cardiac chamber pressure measurement using balloon catheterisation
Interventions
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Electrocardiogram
Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart
Transthoracic echocardiogram
Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound
Right heart catheter
Minimally invasive cardiac chamber pressure measurement using balloon catheterisation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known or suspected congenital heart disease
* Patient has opted-out of allowing their data to be used for research and planning (via the national data opt-out choice in England, or equivalent data protection scheme in Scotland)
18 Years
ALL
No
Sponsors
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Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
Royal Free Hospital NHS Foundation Trust
OTHER
Golden Jubilee National Hospital
OTHER_GOV
Papworth Hospital NHS Foundation Trust
OTHER_GOV
University of Bath
OTHER
Royal United Hospitals Bath NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Daniel X Augustine
Role: PRINCIPAL_INVESTIGATOR
Royal United Hospital
Locations
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Royal United Hospital NHS Foundation Trust
Bath, Banes, United Kingdom
Golden Jubilee Hospital
Glasgow, Lanarkshire, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Royal Papworth Hospital
Cambridge, , United Kingdom
Royal Free NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Martin Johnson
Role: primary
Role: backup
Other Identifiers
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DRAPE
Identifier Type: -
Identifier Source: org_study_id
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