Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06386185

Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal United Hospital NHS Foundation Trust, Bath, Banes, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Electrocardiogram

Diagnostic Test

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

Other names: ECG

Transthoracic Echocardiogram

Diagnostic Test

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

Other names: Echo, TTE

Right heart catheter

Diagnostic Test

Minimally invasive cardiac chamber pressure measurement using balloon catheterisation

Other names: RHC

Primary outcomes

  1. Distinguish between patients with and without pulmonary hypertension

    Time frame: 2 years

    Assessment of novel echo markers of cardiac function in improving the current assessment framework's ability to correctly identify or exclude the presence of pulmonary hypertension based on a mean pulmonary artery pressure greater than 20mmHg as measured by right heart catheter.

    There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension

  2. Distinguish between patients with pre-capillary hypertension and post-capillary hypertension

    Time frame: 2 years

    Assessment of novel echo markers of cardiac function in determining the subtype of pulmonary hypertension (i.e. pulmonary hypertension secondary to left heart disease, or pulmonary hypertension emanating from pulmonary abnormality) based on a mean pulmonary artery pressure greater than 20mmHg, pulmonary vascular resistance, or pulmonary capillary wedge pressure as measured by right heart catheter.

    There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension

Secondary outcomes

  1. Assess the impact of the severity of pulmonary hypertension

    Time frame: 2 years

    Existing research has demonstrated that current assessment guidelines are less accurate in milder forms of pulmonary hypertension. We aim to assess any improvements to the overall efficacy that novel markers of cardiac function may have, particularly in those with low echocardiographic probability as determined by European Society of Cardiology echocardiographic guidelines for the assessment of pulmonary hypertension.

    There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension

  2. Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification

    Time frame: 2 years

    Assessment of novel electrocardiogram markers in improving pulmonary hypertension assessment guidelines, particularly in those with low echocardiographic probability as determined by European Society of Cardiology echocardiographic guidelines for the assessment of pulmonary hypertension.

    There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Wild

CONTACT

[email protected]

+4407891662866

Jane Carter

CONTACT

[email protected]

+4401225821905

Sponsors and collaborators

Lead sponsor

Royal United Hospitals Bath NHS Foundation Trust

Other

Collaborators

  • Golden Jubilee National Hospital
  • Papworth Hospital NHS Foundation Trust
  • Royal Free Hospital NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • University of Bath

Registry information

Acronym: DRAPE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.