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
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
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.
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