Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

Pulmonary Hypertension Clinical Trial

— DRAPE  

Official title:

Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386185
• Other study ID #: DRAPE
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: November 1, 2026

Study information

• Verified date: April 2024
• Source: Royal United Hospitals Bath NHS Foundation Trust
• Contact: Christopher Wild
• Phone: 07891662866
• Email: chris.wild1[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: November 1, 2026
• Est. primary completion date: July 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• Electrocardiogram
Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart
• Transthoracic echocardiogram
Non-invasive 2 & 3 dimensional imaging of the heart using ultrasound
• Right heart catheter
Minimally invasive cardiac chamber pressure measurement using balloon catheterisation

Locations

Country	Name	City	State
United Kingdom	Royal United Hospital NHS Foundation Trust	Bath	Banes
United Kingdom	Royal Papworth Hospital	Cambridge
United Kingdom	Golden Jubilee Hospital	Glasgow	Lanarkshire
United Kingdom	Royal Free NHS Foundation Trust	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (6)

Lead Sponsor	Collaborator
Royal United Hospitals Bath NHS Foundation Trust	Golden Jubilee National Hospital, Papworth Hospital NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 PH	2 years
Primary	Distinguish between patients with pre-capillary hypertension and post-capillary hypertension	Assessment of novel echo markers of cardiac function in determining the subtype of PH (i.e. PH secondary to left heart disease, or PH emanating from pulmonary abnormality)	2 years
Secondary	Assess the impact of the severity of pulmonary hypertension	Existing research has demonstrated that current assessment guidelines are less accurate in milder forms of PH. We aim to assess any improvements to the overall efficacy that novel markers of cardiac function may have.	2 years
Secondary	Assess the impact of additional ECG markers on existing PH probability stratification	Assessment of novel ECG markers in improving PH assessment guidelines	2 years