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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

NCT04480723 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Clinical Trial · Actelion

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2022-05-13
Completion
2022-05-18

Countries

  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480723 on ClinicalTrials.gov