Improving Pulmonary Hypertension Screening by Echocardiography

Pulmonary Hypertension Clinical Trial

— IMPULSE  

Official title:

Improving Pulmonary Hypertension Screening by Echocardiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06038149
• Other study ID #: IMPULSE
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Royal United Hospitals Bath NHS Foundation Trust
• Contact: Christopher JB Wild, BSc(Hons)
• Phone: 07891662866
• Email: chris.wild1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• Transthoracic echocardiogram
A painless ultrasound scan of the heart.

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital NHS Foundation Trust	Bath	Banes
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Golden Jubilee Hospital	Glasgow	Lanarkshire
United Kingdom	Royal Free NHS Foundation Trust	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (8)

Lead Sponsor	Collaborator
Royal United Hospitals Bath NHS Foundation Trust	Golden Jubilee National Hospital, Janssen-Cilag Ltd., Liverpool John Moores University, Royal Free Hospital NHS Foundation Trust, Royal Papworth Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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