Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal United Hospitals Bath NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Electrocardiogram

    Diagnostic test

    Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart

  • Transthoracic echocardiogram

    Diagnostic test

    Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound

  • Right heart catheter

    Diagnostic test

    Minimally invasive cardiac chamber pressure measurement using balloon catheterisation

Treatment groups

2,500 Participants
are divided into 1 treatment group
Group A: Diagnostic Test3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
2 years
2

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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