Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Electrocardiogram, Transthoracic echocardiogram, Right heart catheter.
- Who it may be relevant to
- Registry conditions: Pulmonary Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Electrocardiogram
Non-invasive multi-vector voltage/time graph visualising the electrical conduction of the heart - Diagnostic test Transthoracic echocardiogram
Non-invasive 2 \& 3 dimensional imaging of the heart using ultrasound - Diagnostic test Right heart catheter
Minimally invasive cardiac chamber pressure measurement using balloon catheterisation
Primary outcome measures
- Distinguish between patients with and without pulmonary hypertension [Time frame: 2 years]
- Distinguish between patients with pre-capillary hypertension and post-capillary hypertension [Time frame: 2 years]
Secondary outcome measures (2)
- Assess the impact of the severity of pulmonary hypertension [Time frame: 2 years]
- Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification [Time frame: 2 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 5 centers
- Royal United Hospital NHS Foundation Trust — Bath
- Golden Jubilee Hospital — Glasgow
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield
- Royal Papworth Hospital — Cambridge
- Royal Free NHS Foundation Trust — London
Identifiers
NCT: NCT06386185 · DRAPE