Validation of 4-strata risk assessment in medically managed CTEPH
Research type
Research Study
Full title
Validation of a novel 4-strata risk assessment strategy in medically-managed chronic thromboembolic pulmonary hypertension.
IRAS ID
307471
Contact name
Alistair Colin Church
Contact email
Sponsor organisation
NHS National Waiting Times Centre
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Pulmonary hypertension (PH) is a condition caused by high blood pressure within the blood vessels of the lungs. PH is classified into 5 groups; Group I is a primary disease of the pulmonary blood vessels and Group IV (also known as chronic thromboembolic disease, CTEPH) is where long standing scarring and blot clots in the lungs lead to PH. Some patients with Group IV PH can undergo an operation to improve this condition.
Current PH guidelines advocate the use of risk stratification to predict prognosis and to identify the need for intensifying treatment. Risk is calculated by assessing the severity of multiple variables. European guidelines recommend the use of an assessment tool, whereby patients are stratified into a 3-strata method of low- (<5% mortality at one year), intermediate- (5-10% risk) and high-risk (>10%). Different approaches have been taken as to how this system is implemented; two European groups developed an integer score method, where a value of 1,2 or 3 is assigned to low, intermediate and high-risk variables respectively and an average calculated.
However, the 3-strata system has flaws; few patients achieve a low-risk profile using these criteria. Furthermore, the majority of patients are classified as intermediate-risk which therefore devalues the utility of the system.
A 4-strata approach has been proposed, whereby patients are split into low risk, intermediate-low risk, intermediate-high risk and high risk. This has shown promising results in patients with Group I PH but has yet to be validated in patients with Group IV PH. This study aims to validate the 4-strata system in patients with Group IV PH, using retrospective data, who are unable to have an operation or have residual PH after the operation.
REC name
London - Riverside Research Ethics Committee
REC reference
21/PR/1607
Date of REC Opinion
21 Jan 2022
REC opinion
Further Information Favourable Opinion