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Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

Sponsor: Royal United Hospitals Bath NHS Foundation Trust

NCT ID: NCT06386185

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Electrocardiogram (diagnostic test), Transthoracic echocardiogram (diagnostic test), Right heart catheter (diagnostic test)
How long the study runs
Study runs about 27 months (dates as stated)
About the drug or intervention
Electrocardiogram — diagnostic test: Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart · Transthoracic echocardiogram — diagnostic test: Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound · Right heart catheter — diagnostic test: Minimally invasive cardiac chamber pressure measurement using balloon catheterisation
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
2,500
Started
2024-09-06
Last checked
2025-06

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary hypertension
  • • Clinical study - 2,500 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with pulmonary hypertension

Where?

  • • Bath - Royal United Hospital NHS Foundation Trust
  • • Glasgow - Golden Jubilee Hospital
  • • Sheffield - Sheffield Teaching Hospitals NHS Foundation Trust
  • • Cambridge - Royal Papworth Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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?

More detail

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.

Pulmonary Hypertension

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗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...
See the full criteria
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)

Where Is This Study? (5 UK sites)

Royal United Hospital NHS Foundation Trust

Bath BA1 3NG, United Kingdom

Recruiting
Site contact (verified)
Daniel X Augustine, MBBSPrincipal Investigator
Christopher JB Wild, BSc (Hons)07891662866chris.wild1@nhs.net

Golden Jubilee Hospital

Glasgow G81 4DY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Martin JohnsonPrincipal Investigator

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2JF, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Thanos CharalampopoulousPrincipal Investigator
Thanos Charalampopoulousathanasios.charalampopoulos@nhs.net

Royal Papworth Hospital

Cambridge CB2 0AY, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Madalina GarbiPrincipal Investigator

Royal Free NHS Foundation Trust

London NW3 2QG, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Gerry CoghlanPrincipal Investigator

How to Get in Touch

Christopher Wild

Sponsor contact

CONTACT

+4407891662866 chris.wild1@nhs.net

Jane Carter

Sponsor contact

CONTACT

+4401225821905 jane.carter14@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2025-06