ADOPT: Improving Diagnosis of Pulmonary Hypertension With AI and Echo

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients aged ≥18.

- Have undergone a transthoracic echo and right heart catheter as part of their routine clinical care.

Exclusion Criteria:

- Patients aged <18.

- Known or suspected congenital heart disease.

- Patient opted out of allowing their information to be used for research and planning (via the national data opt-out choice).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06145880
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Royal United Hospitals Bath NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension

Additional Details

In this study the investigators will gather retrospective echo images from 5 specialist PH hospitals across the UK (Royal Free Hospital NHS FT; Sheffield Teaching Hospitals NHS FT; Royal Papworth Hospital NHS FT; NHS Golden Jubilee National Hospital Glasgow; Royal United Hospitals Bath NHS FT). 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 PH absent. Inclusion criteria involve patients aged ≥18 who have undergone both a transthoracic echo (TTE) and a right heart catheter (RHC) as part of their clinical care. Exclusion Criteria will involve patients aged <18, known or suspected congenital heart disease and patients who have opted out of allowing their information to be used for research and planning (via the national data opt-out choice). A clinical case report form (CRF) will be used to capture patient demographics, clinical data with regards to the PH assessment including previous TTE results. Where available, mortality data will be recorded within 5 years of the RHC. These anonymised echo images will be collated and labelled centrally in a core lab at the RUH Bath, who will work with Janssen to develop and train an AI tool to identify scans where PH is present, including which specific type of PH may be present. AI tool training will be based on 5 groups (each group anticipated to contain 415 echocardiograms): mild pre-capillary PH; moderate pre-capillary PH; severe pre-capillary PH; post capillary PH; no PH. The tool will then be validated in a separate pool made up of 425 echocardiograms (a combination of pre-capillary, post capillary PH and no PH). The validation cohort will not have been used in the training stage.

Arms & Interventions

Arms

: Mild pre-capillary PH

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

: Moderate pre-capillary PH

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

: Severe pre-capillary PH

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

: Post capillary PH

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

: No PH

Right heart catheterisation (performed as part of usual care) demonstrates normal pulmonary pressures (i.e. no evidence of pulmonary hypertension).

Interventions

Diagnostic Test: - Artificial intelligence tool for transthoracic echocardiography

Pre-defined cohorts will be used to train the artificial intelligence tool for transthoracic echocardiography to improve the diagnosis of PH on TTE.

Contact a Trial Team

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