Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

NCT ID: NCT06386185

Last Updated: 2025-06-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-06

Study Completion Date

2026-12-01

Brief Summary

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The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.

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?

Detailed Description

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Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal.

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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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart

Transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound

Right heart catheter

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Transthoracic echocardiogram

Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound

Intervention Type DIAGNOSTIC_TEST

Right heart catheter

Minimally invasive cardiac chamber pressure measurement using balloon catheterisation

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ECG Echo TTE RHC

Eligibility Criteria

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Inclusion Criteria

* Patients 18+ who have undergone TTE, ECG and RHC as part of their clinical care

Exclusion Criteria

* Patients \<18 years old
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Bath

OTHER

Sponsor Role collaborator

Royal United Hospitals Bath NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Golden Jubilee Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status NOT_YET_RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status NOT_YET_RECRUITING

Royal Papworth Hospital

Cambridge, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Free NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United Kingdom

Central Contacts

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Christopher Wild

Role: CONTACT

+4407891662866

Jane Carter

Role: CONTACT

+4401225821905

Facility Contacts

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Christopher JB Wild, BSc (Hons)

Role: primary

07891662866

Jane Carter

Role: backup

01225 824295

Martin Johnson

Role: primary

Role: backup

Thanos Charalampopoulous

Role: primary

Madalina Garbi

Role: primary

Gerry Coghlan

Role: primary

Other Identifiers

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DRAPE

Identifier Type: -

Identifier Source: org_study_id

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