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
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Participants with Low or Intermediate Probability of PH 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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 Biomarker Results [Up to 90 Days]
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 [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
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Referred for diagnostic work-up for pulmonary hypertension (PH)
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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
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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
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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
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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:
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Undergone RHC within 2 years
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Participants requiring renal dialysis
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Participants post-lung or heart transplant
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Severe left ventricular dysfunction: left ventricular ejection fraction less then (<) 35 percent
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Ongoing Contagious respiratory disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitatsklinikum Bonn | Bonn | Germany | 53105 | |
| 2 | Universitaetsklinikum Giessen | Giessen | Germany | 35392 | |
| 3 | Universitätsklinikum Schleswig-Holstein | Luebeck | Germany | 23538 | |
| 4 | Royal United Hospital | Bath | United Kingdom | BA1 3NG | |
| 5 | National Waiting Times Centre Board Golden Jubilee National Hospital | Glasgow | United Kingdom | G81 4DY | |
| 6 | Royal Free Hospital | London | United Kingdom | NW3 2QG | |
| 7 | Hammersmith Hospital | London | United Kingdom | W12 0HS | |
| 8 | Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital | Sheffield | United Kingdom | S10 2RX |
Sponsors and Collaborators
- Actelion
Investigators
- Study Director: Actelion Clinical Trial, Actelion
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108827
- NAPUH0003