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| ID | Type | Description | Link |
|---|---|---|---|
| NAPUH0001 | Other Identifier | Janssen Research & Development, LLC |
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The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with PH and non-PH | Other | Blood samples will be collected for biomarker analysis from new (incident) and existing (prevalent) participants who undergo right heart catheterization (RHC). Participants will be categorized into non-PH or PH based on the results of the RHC and those who are found to have PH will be further classified into the different groups of PH. A transthoracic echocardiography (TTE) will be performed if not done previously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample | Other | Prevalent (existing) and incident (new) participants who are found to either have PH or not by RHC will provide blood sample for the establishment of a biomarker signature of PH. |
| Measure | Description | Time Frame |
|---|---|---|
| Expression Levels of miRNAs Biomarkers | Blood samples will be collected for micro Ribonucleic acid (miRNA) assay by qPCR to identify a biomarker signature for the early detection of pulmonary hypertension (PH). | Day 1 |
| Biomarker signatures for miRNA | Blood will be collected for miRNA to identify a biomarker signature(s) for detection of participants at high risk of PH. | Day 1 |
| Biomarker Signature Performance in Identifying Participants with PH | Biomarker signature performance will be evaluated by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the biomarker signatures documented by RHC for identifying participants with PH. | Day 1 |
| Comparison of Performance of Biomarker Signatures and Transthoracic Echocardiogram (TTE) Based on Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value | The performance of the biomarkers signatures will be compared to the performance of TTE to identify participants with PH documented by RHC via sensitivity, specificity, positive predictive value, and negative predictive value. The sensitivity/specificity of the tests will be compared using McNemar's test. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy | Performance of the biomarker signatures will be assessed using ROC curve in participants with PH who are receiving pulmonary arterial hypertension-specific drug therapies versus participants who are not receiving any drug therapy. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| University Of Colorado Cardiac And Vascular Center |
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| Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH | Performance of the biomarker signatures will be assessed using ROC curve in participants with pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), isolated pre-capillary and post-capillary PH. | Day 1 |
| Aurora |
| Colorado |
| 80045-2548 |
| United States |
| Ascension St. Vincent's Lung Institute | Jacksonville | Florida | 32204 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| University Of Iowa - Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| Norton Pulmonary Specialists | Louisville | Kentucky | 40202 | United States |
| LSU Health Sciences Center New Orleans | New Orleans | Louisiana | 70112 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111-1552 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5990 | United States |
| Pulmonary Health Physicians, PC | Liverpool | New York | 13088 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8550 | United States |
| The Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Pulmonary Associates Of Richmond | Richmond | Virginia | 23230 | United States |
| ULB Erasme Ziekenhuis | Brussels | 1070 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Brest - Hopital de la Cavale Blanche | Brest | 29200 | France |
| Hopital de Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| Hôpital Cardiologique - Chru Lille | Lille | 59037 | France |
| CHU de Montpellier - Arnaud de Villeneuve | Montpellier | 34295 | France |
| Hopital Larrey CHU de Toulouse | Toulouse | 31059 | France |
| Universitatsklinikum Bonn | Bonn | 53105 | Germany |
| Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie | Dresden | 01307 | Germany |
| Universitaetsklinikum Giessen | Giessen | 35392 | Germany |
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| Lungenfachklinik Immenhausen | Immenhaus | 34376 | Germany |
| Universitätsklinikum Jena Klinik für Innere Medizin I | Jena | 07747 | Germany |
| Universitatsklinikum Schleswig Holstein | Lübeck | 23538 | Germany |
| VUMC Amsterdam | Amsterdam | 1007 MB | Netherlands |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego | Lublin | 20 718 | Poland |
| Europejskie Centrum Zdrowia Otwock Sp z o o | Otwock | 05 400 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 2 PUM | Szczecin | 70-111 | Poland |
| Hosp Univ Vall D Hebron | Barcelona | 8035 | Spain |
| Hosp Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp Clinico Univ de Salamanca | Salamanca | 37008 | Spain |
| Hosp. Univ. Marques de Valdecilla | Santander | 39008 | Spain |
| Hosp. Virgen de La Salud | Toledo | 45004 | Spain |
| CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council' | Cherkasy | 18009 | Ukraine |
| CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery' | Dnipro | 49070 | Ukraine |
| SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine | Kyiv | 02000 | Ukraine |
| SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine' | Kyiv | 03038 | Ukraine |
| 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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