Improving Pulmonary Hypertension Screening by Echocardiography

NCT06038149 | Active Not Recruiting

• 1 other identifier: IMPULSE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension

  Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm on the assessment of PH.

  18 months

• Analysis of the IMPULSE algorithm in comparison to existing guidlines

  Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm in comparison with the existing ESC PH guidelines.

  18 months

Secondary Outcomes (3)

• Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.

  18 months

• Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.

  18 months

• Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.

  18 months

Study Arms (2)

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.

Diagnostic Test: Transthoracic echocardiogram

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.

Diagnostic Test: Transthoracic echocardiogram

Interventions

Transthoracic echocardiogram DIAGNOSTIC_TEST

A painless ultrasound scan of the heart.

Also known as: TTE

Intermediate PH probability; Low PH probability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred into a UK pulmonary hypertension centre for the first time, determined to be of low/intermediate probability of pulmonary hypertension on routine echocardiogram.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• Janssen-Cilag Ltd.: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Royal Papworth Hospital: collaborator
• Golden Jubilee National Hospital: collaborator
• University of Bath: collaborator
• Liverpool John Moores University: collaborator

Study Sites (5)

Royal United Hospital NHS Foundation Trust

Bath, Banes, BA1 3NG, United Kingdom

Location

Golden Jubilee Hospital

Glasgow, Lanarkshire, G81 4DY, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

Location

Royal Free NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Daniel X Augustine, BSc(Hons)

  Royal United Hospitall NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: September 14, 2023
• Study Start: November 11, 2023
• Primary Completion: December 14, 2025
• Study Completion: March 20, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data obtained will be made available during the data collection period and transferred in batches.
• Access Criteria: Transfer via internal NHS DICOM servers

Locations

GB (5)