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)
Europejskie Centrum Zdrowia Otwock Sp. z o.o
馃嚨馃嚤Otwock, Poland
Universitatsklinikum Bonn
馃嚛馃嚜Bonn, Germany
Wojew贸dzki Szpital Specjalistyczny im. Stefana Kardyna艂a Wyszy艅skiego
馃嚨馃嚤Lublin, Poland
Ascension St. Vincent's Lung Institute
馃嚭馃嚫Jacksonville, Florida, United States
Norton Pulmonary Specialists
馃嚭馃嚫Louisville, Kentucky, United States
VUMC Amsterdam
馃嚦馃嚤Amsterdam, Netherlands
Hammersmith Hospital
馃嚞馃嚙London, United Kingdom
Hosp. Univ. Marques de Valdecilla
馃嚜馃嚫Santander, Spain
Hosp. Univ. Vall D Hebron
馃嚜馃嚫Barcelona, Spain
Hosp. Univ. 12 de Octubre
馃嚜馃嚫Madrid, Spain
SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
馃嚭馃嚘Kyiv, Ukraine
Hopital de Bicetre
馃嚝馃嚪Le Kremlin-Bic锚tre, France
Universitaetsklinikum Giessen
馃嚛馃嚜Giessen, Germany
Universit盲tsklinikum Schleswig-Holstein
馃嚛馃嚜Luebeck, Germany
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
馃嚞馃嚙Sheffield, United Kingdom
Thoraxklinik Heidelberg
馃嚛馃嚜Heidelberg, Germany
Hosp. Clinico Univ. de Salamanca
馃嚜馃嚫Salamanca, Spain
Royal Free Hospital
馃嚞馃嚙London, United Kingdom
CHU de Brest - H么pital de la Cavale Blanche
馃嚝馃嚪Brest, France
Hosp. Virgen de La Salud
馃嚜馃嚫Toledo, Spain
Hosp. Clinic I Provincial de Barcelona
馃嚜馃嚫Barcelona, Spain
Lungenfachklinik Immenhausen
馃嚛馃嚜Immenhaus, Germany
Royal United Hospital
馃嚞馃嚙Bath, United Kingdom
National Waiting Times Centre Board Golden Jubilee National Hospital
馃嚞馃嚙Glasgow, United Kingdom
Universit盲tsklinikum Jena Klinik f眉r Innere Medizin I
馃嚛馃嚜Jena, Germany
University Of Colorado Cardiac And Vascular Center
馃嚭馃嚫Aurora, Colorado, United States
University of Southern California
馃嚭馃嚫Los Angeles, California, United States
University Of Iowa - Hospitals & Clinics
馃嚭馃嚫Iowa City, Iowa, United States
Tufts Medical Center
馃嚭馃嚫Boston, Massachusetts, United States
Pulmonary Health Physicians, PC
馃嚭馃嚫Liverpool, New York, United States
UT Southwestern Medical Center
馃嚭馃嚫Dallas, Texas, United States
Hopital Larrey CHU de Toulouse
馃嚝馃嚪Toulouse, France
Pulmonary Associates Of Richmond
馃嚭馃嚫Richmond, Virginia, United States
Universit盲tsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
馃嚛馃嚜Dresden, Germany
H么pital Cardiologique - Chru Lille
馃嚝馃嚪Lille Cedex, France
CHU de Montpellier - Arnaud de Villeneuve
馃嚝馃嚪MONTPELLIER Cedex 5, France
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
馃嚨馃嚤Szczecin, Poland
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
馃嚭馃嚘Dnipro, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
馃嚭馃嚘Kyiv, Ukraine
ULB Erasme Ziekenhuis
馃嚙馃嚜Bruxelles, Belgium
UZ Leuven Gasthuisberg
馃嚙馃嚜Leuven, Belgium
Icahn School of Medicine at Mount Sinai
馃嚭馃嚫New York, New York, United States
University of Cincinnati
馃嚭馃嚫Cincinnati, Ohio, United States
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
馃嚭馃嚘Cherkasy, Ukraine
Mayo Clinic
馃嚭馃嚫Rochester, Minnesota, United States
LSU Health Sciences Center New Orleans
馃嚭馃嚫New Orleans, Louisiana, United States
University of Nebraska Medical Center
馃嚭馃嚫Omaha, Nebraska, United States
The Houston Methodist Research Institute
馃嚭馃嚫Houston, Texas, United States