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

Early Phase 1

Completed

• Conditions: Hypertension, Pulmonary

• Registration Number: NCT04480723
• Lead Sponsor: Actelion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-21
• Study Start: 2020-12-11
• Primary Completion: 2022-05-13
• Study Completion: 2022-05-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Referred for diagnostic work-up for pulmonary hypertension (PH)
• With low or intermediate (but not high) probability of PH by transthoracic echocardiography (TTE) according to European Society of Cardiology (ESC)/ European Respiratory Society (ERS) Guidelines if at the time of enrollment Right Heart Catheterization (RHC) is not deemed to be clinically indicated
• 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 sign an Informed consent (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
• Must sign a separate approval in the ICF if he or she agrees to provide an optional (DNA) sample for research. Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study

Exclusion Criteria

• Undergone RHC within 2 years
• Participants requiring renal dialysis
• Participants post-lung or heart transplant
• Severe left ventricular dysfunction: left ventricular ejection fraction less then (<) 35 percent
• Ongoing Contagious respiratory disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker	Up to 90 Days	Percentage of (transthoracic echocardiography \[TTE\] low/intermediate probability) participants who are positive for the biomarker will be estimated.
Performance of Biomarker Results	Up to 90 Days	The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.
Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI	Up to 90 Days	Percentage of participants considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) will be evaluated.
Performance of the Biomarker Signatures Identified in the CIPHER Study in Terms of Sensitivity, specificity, positive predictive value (PPV) and Negative Predictive Value (NPV), in Participants not Having PH	Up to 90 Days	Performance of the biomarker signatures identified in the CIPHER study in terms of sensitivity, specificity, PPV and NPV, in a population considered clinically as not having PH will be estimated.

Secondary Outcome Measures

Name	Time	Method
Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study	Up to 90 Days	The biomarker data collected from participants with low/intermediate suspicion of PH in the CIPHER-MRI study will be pooled with the data collected from the high to intermediate suspicion of PH participants in the CIPHER (NAPUH0001) study to evaluate the performance of the biomarker signature(s) developed in CIPHER (NAPUH0001).

Trial Locations

Locations (8)

Universitatsklinikum Schleswig Holstein; 🇩🇪 Luebeck, Germany

Universitatsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitaetsklinikum Giessen; 🇩🇪 Giessen, Germany

Royal United Hospital; 🇬🇧 Bath, United Kingdom

National Waiting Times Centre Board Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom