IMPULSE: Improving Pulmonary Hypertension Screening by Echocardiography
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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:
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| 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:
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Outcome Measures
Primary Outcome Measures
- Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension [18 months]
Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm on the assessment of PH.
- Analysis of the IMPULSE algorithm in comparison to existing guidlines [18 months]
Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm in comparison with the existing ESC PH guidelines.
Secondary Outcome Measures
- Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension. [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.
- Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension. [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.
- Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension. [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unexplained breathlessness
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Risk factors for Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH)
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Unexplained elevation of B-type natriuretic peptide (BNP/proBNP)
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Referred for catheterisation.
Exclusion Criteria:
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ESC / BSE echo high probability of PH
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Known or suspected congenital heart disease
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Patients unlikely to benefit from management of PH or its underlying causes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal United Hospital NHS Foundation Trust | Bath | Banes | United Kingdom | BA1 3NG |
| 2 | Golden Jubilee Hospital | Glasgow | Lanarkshire | United Kingdom | G81 4DY |
| 3 | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire | United Kingdom | S10 2JF |
| 4 | Royal Papworth Hospital | Cambridge | United Kingdom | CB2 0AY | |
| 5 | Royal Free NHS Foundation Trust | London | United Kingdom | NW3 2QG |
Sponsors and Collaborators
- Royal United Hospitals Bath NHS Foundation Trust
- Janssen-Cilag Ltd.
- Royal Free Hospital NHS Foundation Trust
- Sheffield Teaching Hospitals NHS Foundation Trust
- Royal Papworth Hospital
- Golden Jubilee National Hospital
- University of Bath
- Liverpool John Moores University
Investigators
- Principal Investigator: Daniel X Augustine, BSc(Hons), Royal United Hospitall NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMPULSE