Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography (DRAPE)

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?

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Diagnostic test: Electrocardiogram; Diagnostic test: Transthoracic echocardiogram; Diagnostic test: Right heart catheter

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 Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Christopher Wild; Phone Number: +4407891662866; Email: chris.wild1@nhs.net
• Study Contact Backup: Name: Jane Carter; Phone Number: +4401225821905; Email: jane.carter14@nhs.net

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Not yet recruiting
    • Royal Papworth Hospital
    • Contact: Madalina Garbi; Email: madalina.garbi@nhs.net
    • Principal Investigator: Madalina Garbi
    • Sub-Investigator: Joana Pepke-Zaba
  • London, United Kingdom, NW3 2QG
    • Not yet recruiting
    • Royal Free NHS Foundation Trust
    • Contact: Gerry Coghlan; Email: gerry.coghlan@nhs.net
    • Principal Investigator: Gerry Coghlan
    • Sub-Investigator: Daniel Knight
  • Banes
    • Bath, Banes, United Kingdom, BA1 3NG
      • Recruiting
      • Royal United Hospital NHS Foundation Trust
      • Contact: Christopher JB Wild, BSc (Hons); Phone Number: 07891662866; Email: chris.wild1@nhs.net
      • Contact: Jane Carter; Phone Number: 01225 824295; Email: jane.carter14@nhs.net
      • Principal Investigator: Daniel X Augustine, MBBS
      • Sub-Investigator: Christopher JB Wild, BSc(Hons)
      • Sub-Investigator: Jay Suntharalingham
      • Sub-Investigator: Robert Mackenzie-Ross
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G81 4DY
      • Not yet recruiting
      • Golden Jubilee Hospital
      • Contact: Martin Johnson
      • Contact: Email: martin.johnson@ggc.scot.nhs.uk
      • Principal Investigator: Martin Johnson
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Not yet recruiting
      • Sheffield Teaching Hospitals NHS Foundation Trust
      • Contact: Thanos Charalampopoulous; Email: athanasios.charalampopoulos@nhs.net
      • Principal Investigator: Thanos Charalampopoulous
      • Sub-Investigator: Abdul Hameed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: Electrocardiogram; Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart; Other Names: ECG; Diagnostic test: Transthoracic echocardiogram; Non-invasive 2 & 3 dimensional imaging of the heart using ultrasound; Other Names: Echo; TTE; Diagnostic test: Right heart catheter; Minimally invasive cardiac chamber pressure measurement using balloon catheterisation; Other Names: RHC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
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	2 years

Collaborators and Investigators

• Sponsor: Royal United Hospitals Bath NHS Foundation Trust
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Free Hospital NHS Foundation Trust; University of Bath; Papworth Hospital NHS Foundation Trust; Golden Jubilee National Hospital
• Investigators: Principal Investigator: Daniel X Augustine, Royal United Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: DRAPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No