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| ID | Type | Description | Link |
|---|---|---|---|
| NAPUH0003 | Other Identifier | Actelion |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Low or Intermediate Probability of PH | Other | Participants who underwent a work-up for the suspicion of PH that includes transthoracic echocardiography (TTE) and who were considered to have a low or intermediate probability of PH according to TTE (local interpretation) will be enrolled. Blood samples will be taken and a cardiac magnetic resonance imaging (MRI) will be performed to evaluate the presence of Pulmonary Hypertension (PH). The TTEs that were performed by local standards will be collected and undergo central interpretation using European society of Cardiology / European respiratory society (ESC/ERS) guidelines to confirm the local interpretation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Other | Blood samples will be taken and analyzed to evaluate the presence of PH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Up to 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Actelion Clinical Trial | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum Bonn | Bonn | 53105 | Germany | |||
| Universitaetsklinikum Giessen |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Cardiac MRI | Diagnostic Test | Cardiac MRI will be performed to evaluate the presence of PH. |
|
| Up to 90 Days |
| Giessen |
| 35392 |
| Germany |
| Universitatsklinikum Schleswig Holstein | Lübeck | 23538 | Germany |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| National Waiting Times Centre Board Golden Jubilee National Hospital | Glasgow | G81 4DY | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital | Sheffield | S10 2RX | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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