Improving Pulmonary Hypertension Screening by Echocardiography (IMPULSE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiogram

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Royal Papworth Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free NHS Foundation Trust
  • Banes
    • Bath, Banes, United Kingdom, BA1 3NG
      • Royal United Hospital NHS Foundation Trust
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G81 4DY
      • Golden Jubilee Hospital
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; A painless ultrasound scan of the heart.; Other Names: TTE
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; A painless ultrasound scan of the heart.; Other Names: TTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.	Values from echocardiographic measures of right heart systolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.	18 months
Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.	Values from echocardiographic measures of right heart diastolic function not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.	18 months
Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.	Values obtained in the echocardiographic assessment of left heart disease not currently used in the ESC/BSE echocardiography pulmonary hypertension, or IMPULSE algorithms will be analysed for sensitivity, specificity, positive predictive value and negative predictive value in context with values obtained during formal pulmonary hypertension diagnosis via right heart catheter, in patients already found to have a mild to intermediate probability of pulmonary hypertension.	18 months

Collaborators and Investigators

• Sponsor: Royal United Hospitals Bath NHS Foundation Trust
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Free Hospital NHS Foundation Trust; University of Bath; Liverpool John Moores University; Janssen-Cilag Ltd.; Golden Jubilee National Hospital; Royal Papworth Hospital
• Investigators: Principal Investigator: Daniel X Augustine, BSc(Hons), Royal United Hospitall NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Actual): December 14, 2025
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: IMPULSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Study documentation will be disseminated to all participating sites on approval.

All research echocardiography data will be transferred to the core lab in the Royal United Hospital Bath for analysis.

• IPD Sharing Time Frame: Data obtained will be made available during the data collection period and transferred in batches.
• IPD Sharing Access Criteria: Transfer via internal NHS DICOM servers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No