Back to resultsA 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
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Blood Sample
Cardiac MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertension, Pulmonary
Eligibility Criteria
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
Sites / Locations
- Universitatsklinikum Bonn
- Universitaetsklinikum Giessen
- Universitätsklinikum Schleswig-Holstein
- Royal United Hospital
- National Waiting Times Centre Board Golden Jubilee National Hospital
- Royal Free Hospital
- Hammersmith Hospital
- Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Participants with Low or Intermediate Probability of PH
Arm Description
Participants who underwent a work-up for the suspicion of PH that includes transthoracic echocardiography (TTE) and who were considered to have a low or intermediate probability of PH according to TTE (local interpretation) will be enrolled. Blood samples will be taken and a cardiac magnetic resonance imaging (MRI) will be performed to evaluate the presence of Pulmonary Hypertension (PH). The TTEs that were performed by local standards will be collected and undergo central interpretation using European society of Cardiology / European respiratory society (ESC/ERS) guidelines to confirm the local interpretation.
Outcomes
Primary Outcome Measures
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.
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.
Performance of Biomarker Results
The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.
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.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04480723
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with Low or Intermediate Probability of PH
Arm Type
Other
Arm Description
Participants who underwent a work-up for the suspicion of PH that includes transthoracic echocardiography (TTE) and who were considered to have a low or intermediate probability of PH according to TTE (local interpretation) will be enrolled. Blood samples will be taken and a cardiac magnetic resonance imaging (MRI) will be performed to evaluate the presence of Pulmonary Hypertension (PH). The TTEs that were performed by local standards will be collected and undergo central interpretation using European society of Cardiology / European respiratory society (ESC/ERS) guidelines to confirm the local interpretation.
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
Blood samples will be taken and analyzed to evaluate the presence of PH.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac MRI
Intervention Description
Cardiac MRI will be performed to evaluate the presence of PH.
Primary Outcome Measure Information:
Title
Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker
Description
Percentage of (transthoracic echocardiography [TTE] low/intermediate probability) participants who are positive for the biomarker will be estimated.
Time Frame
Up to 90 Days
Title
Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI
Description
Percentage of participants considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) will be evaluated.
Time Frame
Up to 90 Days
Title
Performance of Biomarker Results
Description
The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.
Time Frame
Up to 90 Days
Title
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
Description
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.
Time Frame
Up to 90 Days
Secondary Outcome Measure Information:
Title
Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study
Description
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).
Time Frame
Up to 90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Actelion Clinical Trial
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitaetsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
National Waiting Times Centre Board Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
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
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