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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2022-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

NCT04088279

Pulmonary Hypertension

UNKNOWN NA

Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging

NCT01451255

Pulmonary Hypertension Pulmonary Arterial Hypertension

COMPLETED

Cardiac MRI in Pulmonary Hypertension

NCT02485977

Pulmonary Hypertension

COMPLETED

Non-contrast Enhanced Cardiac Magnetic Resonance Imaging in the Diagnosis and Classification of Pulmonary Hypertension

NCT01725763

Pulmonary Hypertension Elevated Mean Pulmonary Arterial Pressure Normal Mean Pulmonary Arterial Pressure

ENROLLING_BY_INVITATION NA

Right Atrial Fibrosis in Pulmonary Hypertension

NCT04663230

Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Arterial Hypertension

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Blood Sample

Intervention Type OTHER

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

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood Sample

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

Intervention Type OTHER

Cardiac MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No