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Active, Not Recruiting

NCT Number: NCT06038149

Improving Pulmonary Hypertension Screening by Echocardiography

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal United Hospital NHS Foundation Trust, Bath, Banes, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transthoracic Echocardiogram

Diagnostic Test

A painless ultrasound scan of the heart.

Other names: TTE

Primary outcomes

  1. Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension

    Time frame: 18 months

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

  2. Analysis of the IMPULSE algorithm in comparison to existing guidlines

    Time frame: 18 months

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

Secondary outcomes

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

    Time frame: 18 months

    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.

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

    Time frame: 18 months

    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.

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

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Royal United Hospitals Bath NHS Foundation Trust

Other

Collaborators

  • 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

Registry information

Acronym: IMPULSE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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