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 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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04480723

Enrollment

Registered

2020-07-21

Start date

2020-12-11

Completion date

2022-05-18

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

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.

Interventions

OTHERBlood Sample

Blood samples will be taken and analyzed to evaluate the presence of PH.

DIAGNOSTIC_TESTCardiac MRI

Cardiac MRI will be performed to evaluate the presence of PH.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026