NCT04193046

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 907 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2019-12-16
• Primary completion: 2021-12-20
• Completion: 2022-02-18
• First posted: 2019-12-10
• Last updated: 2025-09-12

Locations

49 sites across 9 countries: United States, Belgium, France, Germany, Netherlands, Poland, Spain, Ukraine, United Kingdom