Clinical trial NCT06038149: Improving Pulmonary Hypertension Screening by Echocardiography
Official title: Improving Pulmonary Hypertension Screening by Echocardiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
name: Royal Free Hospital NHS Foundation Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Royal Papworth Hospital
name: Golden Jubilee National Hospital
name: University of Bath
name: Liverpool John Moores University
First posted: 2023-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension
timeFrame: 18 months
measure: Analysis of the IMPULSE algorithm in comparison to existing guidlines
timeFrame: 18 months
Secondary outcomes:
measure: Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.
timeFrame: 18 months
measure: Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.
timeFrame: 18 months
measure: Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.
timeFrame: 18 months
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital NHS Foundation Trust
state: Banes
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
state: Lanarkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: London
country: United Kingdom
facility: Royal Free NHS Foundation Trust
Study officials:
affiliation: Royal United Hospitall NHS Foundation Trust
name: Daniel X Augustine, BSc(Hons)
role: PRINCIPAL_INVESTIGATOR
References: