A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
- Conditions
- Hypertension, Pulmonary
- Interventions
- Other: Blood Sample
- Registration Number
- NCT04193046
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 908
- Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
- Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
- Must provide an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [DNA]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study
- Participants requiring renal dialysis
- History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
- Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants with PH and non-PH Blood Sample 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.
- Primary Outcome Measures
Name Time Method Expression Levels of miRNAs Biomarkers Day 1 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).
Biomarker signatures for miRNA Day 1 Blood will be collected for miRNA to identify a biomarker signature(s) for detection of participants at high risk of PH.
Biomarker Signature Performance in Identifying Participants with PH Day 1 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.
Comparison of Performance of Biomarker Signatures and Transthoracic Echocardiogram (TTE) Based on Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value Day 1 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.
- Secondary Outcome Measures
Name Time Method Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy Day 1 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.
Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH Day 1 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.
Trial Locations
- Locations (48)
CHU de Brest - Hopital de la Cavale Blanche
🇫🇷Brest, France
Universitatsklinikum Schleswig Holstein
🇩🇪Luebeck, Germany
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
🇵🇱Lublin, Poland
Europejskie Centrum Zdrowia Otwock Sp z o o
🇵🇱Otwock, Poland
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp Clinico Univ de Salamanca
🇪🇸Salamanca, Spain
University of Southern California
🇺🇸Los Angeles, California, United States
University Of Colorado Cardiac And Vascular Center
🇺🇸Aurora, Colorado, United States
Ascension St. Vincent's Lung Institute
🇺🇸Jacksonville, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
🇺🇦Cherkasy, Ukraine
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
🇺🇦Dnipro, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
🇺🇦Kyiv, Ukraine
Royal United Hospital
🇬🇧Bath, United Kingdom
National Waiting Times Centre Board Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
Hosp. Virgen de La Salud
🇪🇸Toledo, Spain
University Of Iowa - Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Norton Pulmonary Specialists
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Pulmonary Health Physicians, PC
🇺🇸Liverpool, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
Pulmonary Associates Of Richmond
🇺🇸Richmond, Virginia, United States
ULB Erasme Ziekenhuis
🇧🇪Bruxelles, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Hopital de Bicetre
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Cardiologique - Chru Lille
🇫🇷Lille Cedex, France
CHU de Montpellier - Arnaud de Villeneuve
🇫🇷MONTPELLIER Cedex 5, France
Hopital Larrey CHU de Toulouse
🇫🇷Toulouse, France
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
🇩🇪Dresden, Germany
Universitaetsklinikum Giessen
🇩🇪Giessen, Germany
Thoraxklinik Heidelberg
🇩🇪Heidelberg, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhaus, Germany
Universitätsklinikum Jena Klinik für Innere Medizin I
🇩🇪Jena, Germany
VUMC Amsterdam
🇳🇱Amsterdam, Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
🇵🇱Szczecin, Poland
Hosp. Univ. 12 de Octubre
🇪🇸Madrid, Spain
Hosp. Univ. Marques de Valdecilla
🇪🇸Santander, Spain
Hammersmith Hospital
🇬🇧London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom