A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
NCT ID: NCT04193046
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
907 participants
INTERVENTIONAL
2019-12-16
2022-02-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Longitudinal Follow-up Study in Two Chinese Hypertension Cohorts
NCT04471389
Prognostic Value of Plasma Biomarkers Among Patients With Hypertension
NCT04107584
Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
NCT03708601
Adherence of Diuretics in Pulmonary Hypertension
NCT05167968
New Biomarkers and Difficult-to-treat Hypertension
NCT03034265
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with PH and non-PH
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.
Blood Sample
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood Sample
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 (%)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Jacksonville, Florida, United States
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
Mayo Clinic
Rochester, Minnesota, 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
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU de Brest - Hopital de la Cavale Blanche
Brest, , France
Hopital de Bicetre
Le Kremlin-Bicêtre, , France
Hôpital Cardiologique - Chru Lille
Lille, , France
CHU de Montpellier - Arnaud de Villeneuve
Montpellier, , 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
Universitatsklinikum Schleswig Holstein
Lübeck, , Germany
VUMC Amsterdam
Amsterdam, , Netherlands
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
Lublin, , Poland
Europejskie Centrum Zdrowia Otwock Sp z o o
Otwock, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin, , Poland
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp Clinico Univ de Salamanca
Salamanca, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Hosp. Virgen de La Salud
Toledo, , Spain
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
Hammersmith Hospital
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NAPUH0001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108723
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.