Improving Pulmonary Hypertension Screening by Echocardiography

NCT ID: NCT06038149

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-11

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

A painless ultrasound scan of the heart.

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.

Transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

A painless ultrasound scan of the heart.

Interventions

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Transthoracic echocardiogram

A painless ultrasound scan of the heart.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TTE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Royal Papworth Hospital

OTHER_GOV

Sponsor Role collaborator

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

University of Bath

OTHER

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role collaborator

Royal United Hospitals Bath NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel X Augustine, BSc(Hons)

Role: PRINCIPAL_INVESTIGATOR

Royal United Hospitall NHS Foundation Trust

Locations

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Royal United Hospital NHS Foundation Trust

Bath, Banes, United Kingdom

Site Status RECRUITING

Golden Jubilee Hospital

Glasgow, Lanarkshire, United Kingdom

Site Status NOT_YET_RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status RECRUITING

Royal Papworth Hospital

Cambridge, , United Kingdom

Site Status NOT_YET_RECRUITING

Royal Free NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United Kingdom

Central Contacts

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Christopher JB Wild, BSc(Hons)

Role: CONTACT

07891662866

Jane Carter

Role: CONTACT

01225 821095

Facility Contacts

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Christopher JB Wild, BSc (Hons)

Role: primary

07891662866

Jane Carter

Role: backup

01225 824295

Martin Johnson

Role: primary

Role: backup

Thanos Charalampopoulous

Role: primary

Madalina Garbi

Role: primary

Gerry Coghlan

Role: primary

Other Identifiers

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IMPULSE

Identifier Type: -

Identifier Source: org_study_id

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