Clinical trial NCT06386185: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
Official title: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
name: Royal Free Hospital NHS Foundation Trust
name: Golden Jubilee National Hospital
name: Papworth Hospital NHS Foundation Trust
name: University of Bath
First posted: 2024-04-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Distinguish between patients with and without pulmonary hypertension
timeFrame: 2 years
measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension
timeFrame: 2 years
Secondary outcomes:
measure: Assess the impact of the severity of pulmonary hypertension
timeFrame: 2 years
measure: Assess the impact of additional electrocardiogram markers on existing pulmonary hypertension probability stratification
timeFrame: 2 years
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospital NHS Foundation Trust
state: Banes
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
state: Lanarkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
city: London
country: United Kingdom
facility: Royal Free NHS Foundation Trust
Study officials:
affiliation: Royal United Hospital
name: Daniel X Augustine
role: PRINCIPAL_INVESTIGATOR
References: