NCT04480723

A Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging

A Prospective Multicenter Study for the Assessment of Biomarker Signatures for the Diagnosis of Pulmonary Hypertension (PH) in Patients at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging (MRI) CIPHER-MRI

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (micro ribonucleic acid \[RNA\]); estimate the percentage of participants in the population considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) and compare results of the MRI to the biomarker results; to determine the performance of the biomarker signatures identified in the CIPHER (NAPUH0001) study in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), in a population considered clinically as not having PH.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
OTHER	Blood Sample	Blood samples will be taken and analyzed to evaluate the presence of PH.
DIAGNOSTIC_TEST	Cardiac MRI	Cardiac MRI will be performed to evaluate the presence of PH.

Timeline

• Start date: 2020-12-11
• Primary completion: 2022-05-13
• Completion: 2022-05-18
• First posted: 2020-07-21
• Last updated: 2025-03-30

Locations

8 sites across 2 countries: Germany, United Kingdom