Brief Summary

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, and life expectancy ranges from months to years. For some subtypes of PH, effective treatments exist which can improve life expectancy and quality-of-life. Accurate tools for the assessment of PH are therefore essential so that life-saving medications can be started earlier. In existing diagnostic pathways, evidence for the suspicion of PH is frequently overlooked, significantly delaying the time to diagnosis. Echocardiography (echo) is a quick, safe and well-tolerated test requested to investigate breathless patients, and which can provide useful information about the suspicion of PH. However, outside of specialist PH centres, doctors may not routinely look for and comment on the presence of clues to possible PH. The investigators think that using Artificial Intelligence (AI) techniques to read echo's could make their interpretation faster and more reliable. There may also be subtle clues to the presence or severity of PH on echo, less recognisable to the human eye, which AI can identify. In this study the investigators will gather echo images from 5 specialist PH hospitals across the UK which have all been anonymised (patient's name and personal details removed). These will all be historic scans (i.e. have already taken place) and will be grouped into those with PH present (including PH sub-type) or absent. These anonymised echo images will be used to develop and train an AI tool to identify scans where PH is present, including which specific type of PH may be present. The developed AI tool will then be tested on a separate group of scans (not used in the training stage) to validate its performance.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Dec 2023

Geographic Reach

1 country

1 active site

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

September 7, 2023

Completed

3 months until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed

7 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed

Last Updated

November 22, 2024

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

September 7, 2023

Last Update Submit

November 19, 2024

Conditions

Pulmonary Hypertension

Keywords

EchocardiographyArtificial intelligence

Outcome Measures

Primary Outcomes (6)

Detect patients with pulmonary hypertension (PH) with the novel artificial intelligence tool (AIT)
Measure the proportion of patients the developed AIT correctly identifies as having PH.
Month 24
Detect patients without pulmonary hypertension (PH) with the novel artificial intelligence tool (AIT)
Measure the proportion of patients the developed AIT correctly identifies as not having PH.
Month 24
Detect patients with pre-capillary pulmonary hypertension (PH) with the novel artificial intelligence tool (AIT)
Measure the proportion of patients the developed AIT correctly identifies as having pre-capillary PH.
Month 24
Detect patients with post-capillary pulmonary hypertension (PH) with the novel artificial intelligence tool (AIT)
Measure the proportion of patients the developed AIT correctly identifies as having post-capillary PH.
Month 24
Compare the artificial intelligence tool (AIT) performance for detecting pulmonary hypertension (PH) with the current probability criteria
Compare the proportion of patients identified by the AI tool as having PH with the current guideline criteria for diagnosing PH from a TTE.
Month 24
Evaluate early detection capabilities of the artificial intelligence tool (AIT) compared to standard of care clinical diagnosis
Compare the proportion of patients identified by the AI tool as having PH with current standard clinical practice
Month 24

Secondary Outcomes (2)

The novel artificial intelligence tool (AIT) is able to assess the severity of pulmonary hypertension (PH)
Month 24
The artificial intelligence tool (AIT) is able to predict mortality
Month 24

Study Arms (5)

Mild pre-capillary PH

Right heart catheterisation (performed as part of usual care) diagnoses pulmonary hypertension and categorises it as mild and pre-capillary.