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

Hypertension, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480723
• Other study ID #: CR108827
• Secondary ID: NAPUH0003
• Status: Completed
• Phase: Early Phase 1
• Start date: December 11, 2020
• Est. completion date: May 18, 2022

Study information

• Verified date: August 2022
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 18, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitatsklinikum Bonn	Bonn
Germany	Universitaetsklinikum Giessen	Giessen
Germany	Universitätsklinikum Schleswig-Holstein	Luebeck
United Kingdom	Royal United Hospital	Bath
United Kingdom	National Waiting Times Centre Board Golden Jubilee National Hospital	Glasgow
United Kingdom	Hammersmith Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker	Percentage of (transthoracic echocardiography [TTE] low/intermediate probability) participants who are positive for the biomarker will be estimated.	Up to 90 Days
Primary	Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI	Percentage of participants considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) will be evaluated.	Up to 90 Days
Primary	Performance of Biomarker Results	The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.	Up to 90 Days
Primary	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	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.	Up to 90 Days
Secondary	Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study	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).	Up to 90 Days