The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (micro ribonucleic acid \[RNA\]); estimate the percentage of participants in the population considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) and compare results of the MRI to the biomarker results; to determine the performance of the biomarker signatures identified in the CIPHER (NAPUH0001) study in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), in a population considered clinically as not having PH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
86
Blood samples will be taken and analyzed to evaluate the presence of PH.
Cardiac MRI will be performed to evaluate the presence of PH.
Universitatsklinikum Bonn
Bonn, Germany
Universitaetsklinikum Giessen
Giessen, Germany
Universitatsklinikum Schleswig Holstein
Lübeck, Germany
Royal United Hospital
Bath, United Kingdom
National Waiting Times Centre Board Golden Jubilee National Hospital
Glasgow, United Kingdom
Royal Free Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, United Kingdom
Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker
Percentage of (transthoracic echocardiography \[TTE\] low/intermediate probability) participants who are positive for the biomarker will be estimated.
Time frame: Up to 90 Days
Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI
Percentage of participants considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) will be evaluated.
Time frame: Up to 90 Days
Performance of Biomarker Results
The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.
Time frame: Up to 90 Days
Performance of the Biomarker Signatures Identified in the CIPHER Study in Terms of Sensitivity, specificity, positive predictive value (PPV) and Negative Predictive Value (NPV), in Participants not Having PH
Performance of the biomarker signatures identified in the CIPHER study in terms of sensitivity, specificity, PPV and NPV, in a population considered clinically as not having PH will be estimated.
Time frame: Up to 90 Days
Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study
The biomarker data collected from participants with low/intermediate suspicion of PH in the CIPHER-MRI study will be pooled with the data collected from the high to intermediate suspicion of PH participants in the CIPHER (NAPUH0001) study to evaluate the performance of the biomarker signature(s) developed in CIPHER (NAPUH0001).
Time frame: Up to 90 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.