Clinical trial NCT04480723: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypertension, Pulmonary
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker
timeFrame: Up to 90 Days
measure: Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI
timeFrame: Up to 90 Days
measure: Performance of Biomarker Results
timeFrame: Up to 90 Days
measure: 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
timeFrame: Up to 90 Days
Secondary outcomes:
measure: Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study
timeFrame: Up to 90 Days
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen
city: Luebeck
country: Germany
facility: Universitatsklinikum Schleswig Holstein
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Glasgow
country: United Kingdom
facility: National Waiting Times Centre Board Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Study officials:
affiliation: Actelion
name: Actelion Clinical Trial
role: STUDY_DIRECTOR
References: