Improving Pulmonary Hypertension Screening by Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Transthoracic echocardiogram (Diagnostic Test)
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.
干预措施: Transthoracic echocardiogram (Diagnostic Test)
结局指标
主要结局
Analysis of the IMPULSE algorithm in the assessment of pulmonary hypertension
时间窗: 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
时间窗: 18 months
Analyse sensitivity, specificity, positive predictive value, negative predictive value, accuracy of IMPULSE algorithm in comparison with the existing ESC PH guidelines.
次要结局
- Analysis of additional echocardiographic measurements of right heart diastolic function not utilised in the assessment of pulmonary hypertension.(18 months)
- Analysis of additional echocardiographic measurements of left heart function not utilised in the assessment of pulmonary hypertension.(18 months)
- Analysis of additional echocardiographic measurements of right heart systolic function not utilised in the assessment of pulmonary hypertension.(18 months)