Clinical trial NCT04193046: A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
Official title: A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypertension, Pulmonary
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 908
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 (%)

Primary outcomes:
measure: Expression Levels of miRNAs Biomarkers
timeFrame: Day 1
measure: Biomarker signatures for miRNA
timeFrame: Day 1
measure: Biomarker Signature Performance in Identifying Participants with PH
timeFrame: Day 1
measure: Comparison of Performance of Biomarker Signatures and Transthoracic Echocardiogram (TTE) Based on Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value
timeFrame: Day 1
Secondary outcomes:
measure: Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy
timeFrame: Day 1
measure: Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH
timeFrame: Day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Aurora
country: United States
facility: University Of Colorado Cardiac And Vascular Center
state: Colorado
city: Jacksonville
country: United States
facility: Ascension St. Vincent's Lung Institute
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Iowa City
country: United States
facility: University Of Iowa - Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Sciences Center New Orleans
state: Louisiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Liverpool
country: United States
facility: Pulmonary Health Physicians, PC
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The Houston Methodist Research Institute
state: Texas
city: Richmond
country: United States
facility: Pulmonary Associates Of Richmond
state: Virginia
city: Bruxelles
country: Belgium
facility: ULB Erasme Ziekenhuis
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Brest
country: France
facility: CHU de Brest - Hopital de la Cavale Blanche
city: Le Kremlin-Bicêtre
country: France
facility: Hopital de Bicetre
city: Lille Cedex
country: France
facility: Hôpital Cardiologique - Chru Lille
city: MONTPELLIER Cedex 5
country: France
facility: CHU de Montpellier - Arnaud de Villeneuve
city: Toulouse
country: France
facility: Hopital Larrey CHU de Toulouse
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Immenhaus
country: Germany
facility: Lungenfachklinik Immenhausen
city: Jena
country: Germany
facility: Universitätsklinikum Jena Klinik für Innere Medizin I
city: Luebeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Lublin
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Sp z o o
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Santander
country: Spain
facility: Hosp. Univ. Marques de Valdecilla
city: Toledo
country: Spain
facility: Hosp. Virgen de La Salud
city: Cherkasy
country: Ukraine
facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
city: Dnipro
country: Ukraine
facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Glasgow
country: United Kingdom
facility: National Waiting Times Centre Board Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: