Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

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• Conditions: Pulmonary Hypertension
• Interventions: Diagnostic Test: Electrocardiogram; Diagnostic Test: Transthoracic echocardiogram; Diagnostic Test: Right heart catheter

• Registration Number: NCT06386185
• Lead Sponsor: Royal United Hospitals Bath NHS Foundation Trust

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?

Detailed Description

Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal.

PH can be caused by a number of different conditions and life expectancy varies with the underlying cause, ranging from months to years. For some subtypes of PH, effective treatments exist which can significantly improve life expectancy and quality of life. Accurate tools for the assessment of PH are therefore essential, so that we can better understand and predict life expectancy and so that life-saving medications can be started earlier.

Once doctors suspect that somebody has PH, they refer them to a specialist PH centre for assessment and a procedure called right heart catheterisation (RHC), which will confirm the diagnosis. However, evidence for the suspicion of PH is frequently overlooked, leading to an average delay to diagnosis from onset of symptoms of two years. This late presentation negatively impacts survival for these patients and prevents them promptly starting the effective treatments which are available.

An electrocardiogram (ECG) is a recording of the heart's electrical signals, printed in waveforms. It is a painless, low-cost, and readily-available test used in PH assessment.

Echocardiography (echo) is a quick, safe and well-tolerated test often requested to investigate breathless patients and can provide useful information about the suspicion of PH. Echo has however been shown to lack accuracy in milder forms of the disease. It has been hypothesised that subtle markers of right ventricular function by echo, such as free wall strain (RVFWS) begin to deteriorate before the more established findings.

A large, cross-population study of ECG features and echo markers such as RVFWS both in isolation and in combination, in patients referred for PH assessment may help identify these markers, and improve detection of the disease.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic Test	Transthoracic echocardiogram	Patients referred for initial PH investigations, who underwent ECG and echo screening prior to RHC.
Diagnostic Test	Right heart catheter	Patients referred for initial PH investigations, who underwent ECG and echo screening prior to RHC.
Diagnostic Test	Electrocardiogram	Patients referred for initial PH investigations, who underwent ECG and echo screening prior to RHC.

Primary Outcome Measures

Name	Time	Method
Distinguish between patients with and without pulmonary hypertension	2 years	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	2 years	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 Outcome Measures

Name	Time	Method
Assess the impact of the severity of pulmonary hypertension	2 years	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	2 years	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

Trial Locations

Locations (5)

Golden Jubilee Hospital; 🇬🇧 Glasgow, Lanarkshire, United Kingdom

Royal United Hospital NHS Foundation Trust; 🇬🇧 Bath, Banes, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Royal Papworth Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Free NHS Foundation Trust; 🇬🇧 London, United Kingdom