Improving Pulmonary Hypertension Screening by Echocardiography

Study Purpose

This study aims to assess the application of the novel IMPULSE algorithm for the detection of pulmonary hypertension (PH) in those with a low or intermediate probability of PH according to the British Society of Echocardiography (ESC) and European Society of Cardiology (ESC) guidelines.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
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:

- Unexplained breathlessness.

- Risk factors for Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH) - Unexplained elevation of B-type natriuretic peptide (BNP/proBNP) - Referred for catheterisation.

Exclusion Criteria:

- ESC / BSE echo high probability of PH.

- Known or suspected congenital heart disease.

- Patients unlikely to benefit from management of PH or its underlying causes.

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.	NCT06038149
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.	Daniel X Augustine, BSc(Hons)
Principal Investigator Affiliation	Royal United Hospitall NHS Foundation Trust
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

This is a prospective, multi-centre cross-sectional study with a planned 18 month longitudinal component. Participants will be recruited from patients referred for the first time for transthoracic echocardiography at the Royal United Hospitals Bath National Health Service (NHS) Foundation Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals, Royal Papworth Hospital, and Golden Jubilee Hospital. The investigators will prospectively recruit patients without a diagnosis of Pulmonary Hypertension. Transthoracic echocardiographic (TTE) imaging will be performed in line with British Society of Echocardiography minimum dataset guidelines, and comprehensive right heart echocardiographic imaging and analysis will be performed following the British Society of Echocardiography recommendations for assessing right heart function, in addition to the IMPULSE algorithm; A right ventricular free wall longitudinal strain value of less than -23%, or, right ventricular fractional area change (FAC) less than 35% in females/30% in males, in addition to a right ventricular isovolumetric relaxation time in excess of 73ms in patients with low/Intermediate probability of PH by current guidelines would categorise that patient as being IMPULSE positive.

Arms & Interventions

Arms

: Low PH probability

Individuals identified as being of a low risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.

: Intermediate PH probability

Individuals identified as being of an intermediate risk of pulmonary hypertension on routine echocardiography through existing British Society of Echocardiography/ European Society of Cardiology guidelines will undergo a research echocardiogram on the day of their planned right heart catheter.

Interventions

Diagnostic Test: - Transthoracic echocardiogram

A painless ultrasound scan of the heart.

Contact a Trial Team

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