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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
| Royal Free Hospital NHS Foundation Trust | OTHER |
| Sheffield Teaching Hospitals NHS Foundation Trust | OTHER |
| Royal Papworth Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transthoracic echocardiogram | Diagnostic Test | A painless ultrasound scan of the heart. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel X Augustine, BSc(Hons) | Royal United Hospitall NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospital NHS Foundation Trust | Bath | Banes | BA1 3NG | United Kingdom | ||
| Golden Jubilee Hospital |
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.
Data obtained will be made available during the data collection period and transferred in batches.
Transfer via internal NHS DICOM servers
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER_GOV |
| Golden Jubilee National Hospital | OTHER_GOV |
| University of Bath | OTHER |
| Liverpool John Moores University | OTHER |
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| 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 |
| Glasgow |
| Lanarkshire |
| G81 4DY |
| United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Royal Papworth Hospital | Cambridge | CB2 0AY | United Kingdom |
| Royal Free NHS Foundation Trust | London | NW3 2QG | United Kingdom |
| D002318 |
| Cardiovascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |