A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)

Completed · Early Phase 1

Conditions studied: Hypertension, Pulmonary

In brief

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.

Key facts

Study ID

NCT04193046

Run by

Janssen Research & Development, LLC

People needed

907

Starts

2019-12-16

Expected to finish

2022-02-18

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 (%)

Where it is running

• 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

Full record on ClinicalTrials.gov

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