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: Not yet 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: 07891662866; Email: chris.wild1@nhs.net
• Study Contact Backup: Name: Jane Carter; Phone Number: 01225821905; Email: jane.carter14@nhs.net

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Royal Papworth Hospital
  • London, United Kingdom, NW3 2QG
    • Royal Free NHS Foundation Trust
  • Banes
    • Bath, Banes, United Kingdom, BA1 3NG
      • Royal United Hospital NHS Foundation Trust
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G81 4DY
      • Golden Jubilee Hospital
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS Foundation Trust

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 PH	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 PH (i.e. PH secondary to left heart disease, or PH emanating from pulmonary abnormality)	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 PH. We aim to assess any improvements to the overall efficacy that novel markers of cardiac function may have.	2 years
Assess the impact of additional ECG markers on existing PH probability stratification	Assessment of novel ECG markers in improving PH assessment guidelines	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 (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 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): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular 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