Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

NCT06386185 | Recruiting

• 1 other identifier: DRAPE
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 5

Brief Summary

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?

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• 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

  2 years

• 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

  2 years

Secondary Outcomes (2)

• Assess the impact of the severity of pulmonary hypertension

  2 years

• Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification

  2 years

Study Arms (1)

Diagnostic Test

Patients referred for initial PH investigations, who underwent ECG and echo screening prior to RHC.

Diagnostic Test: Electrocardiogram; Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: Right heart catheter

Interventions

Electrocardiogram DIAGNOSTIC_TEST

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

Also known as: ECG

Diagnostic Test

Transthoracic echocardiogram DIAGNOSTIC_TEST

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

Also known as: Echo, TTE

Diagnostic Test

Right heart catheter DIAGNOSTIC_TEST

Minimally invasive cardiac chamber pressure measurement using balloon catheterisation

Also known as: RHC

Diagnostic Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18+ referred for first time assessment of PH, who have undergone ECG, TTE, and RHC as part of their routine investigation.

You may qualify if:

• Patients 18+ who have undergone TTE, ECG and RHC as part of their clinical care

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• 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

Study Sites (5)

Royal United Hospital NHS Foundation Trust

Bath, Banes, BA1 3NG, United Kingdom

RECRUITING

Golden Jubilee Hospital

Glasgow, Lanarkshire, G81 4DY, United Kingdom

NOT YET RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

NOT YET RECRUITING

Royal Papworth Hospital

Cambridge, CB2 0AY, United Kingdom

NOT YET RECRUITING

Royal Free NHS Foundation Trust

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Electrocardiography; Echocardiography; Caves

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Daniel X Augustine

  Royal United Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Wild

CONTACT

+4407891662866; chris.wild1@nhs.net

Jane Carter

CONTACT

+4401225821905; jane.carter14@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)