About this trial
The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.
The main questions it aims to answer are:
Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18+ who have undergone TTE, ECG and RHC as part of their clinical care
Disqualifiers
Patients <18 years old
Known or suspected congenital heart disease
Patient has opted-out of allowing their data to be used for research and planning (via the national data opt-out choice in England, or equivalent data protection scheme in Scotland)
Trial population
Patients aged 18+ referred for first time assessment of PH, who have undergone ECG, TTE, and RHC as part of their routine investigation.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Electrocardiogram
Diagnostic testNon-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart
Transthoracic echocardiogram
Diagnostic testNon-invasive 2 \& 3 dimensional imaging of the heart using ultrasound
Right heart catheter
Diagnostic testMinimally invasive cardiac chamber pressure measurement using balloon catheterisation
Treatment groups
Trial outcomes
Primary outcomes
Distinguish between patients with and without pulmonary hypertension
Assessment of novel echo markers of cardiac function in improving the current assessment framework's ability to correctly identify or exclude the presence of pulmonary hypertension based on a mean pulmonary artery pressure greater than 20mmHg as measured by right heart catheter. There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension
Distinguish between patients with pre-capillary hypertension and post-capillary hypertension
Assessment of novel echo markers of cardiac function in determining the subtype of pulmonary hypertension (i.e. pulmonary hypertension secondary to left heart disease, or pulmonary hypertension emanating from pulmonary abnormality) based on a mean pulmonary artery pressure greater than 20mmHg, pulmonary vascular resistance, or pulmonary capillary wedge pressure as measured by right heart catheter. There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension
Secondary outcomes
Assess the impact of the severity of pulmonary hypertension
Existing research has demonstrated that current assessment guidelines are less accurate in milder forms of pulmonary hypertension. We aim to assess any improvements to the overall efficacy that novel markers of cardiac function may have, particularly in those with low echocardiographic probability as determined by European Society of Cardiology echocardiographic guidelines for the assessment of pulmonary hypertension. There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension
Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification
Assessment of novel electrocardiogram markers in improving pulmonary hypertension assessment guidelines, particularly in those with low echocardiographic probability as determined by European Society of Cardiology echocardiographic guidelines for the assessment of pulmonary hypertension. There is no reporting scale, rather markers will be used to assess a binary yes/no with regards to the presence of pulmonary hypertension
Sponsors and contacts
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Royal United Hospitals Bath NHS Foundation Trust
Lead sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
Golden Jubilee National Hospital
Collaborator
Papworth Hospital NHS Foundation Trust
Collaborator
University of Bath
Collaborator