Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386185
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-23
Brief Title:
Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
Sponsor:
Royal United Hospitals Bath NHS Foundation Trust
Organization:
Royal United Hospitals Bath NHS Foundation Trust
Study Overview
Official Title:
Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRAPE
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
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 hearts 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
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 hearts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None