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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04480723
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Actelion Clinical Trial
Principal Investigator Affiliation Actelion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universitatsklinikum Bonn, Bonn, Germany

Status

Recruiting

Address

Universitatsklinikum Bonn

Bonn, , 53105

Universitaetsklinikum Giessen, Giessen, Germany

Status

Recruiting

Address

Universitaetsklinikum Giessen

Giessen, , 35392

Universitätsklinikum Schleswig-Holstein, Luebeck, Germany

Status

Recruiting

Address

Universitätsklinikum Schleswig-Holstein

Luebeck, , 23538

Royal United Hospital, Bath, United Kingdom

Status

Completed

Address

Royal United Hospital

Bath, , BA1 3NG

Cambridge, United Kingdom

Status

Withdrawn

Address

Royal Papworth Hospital NHS Foundation Trust

Cambridge, , CB2 0AY

Glasgow, United Kingdom

Status

Completed

Address

National Waiting Times Centre Board Golden Jubilee National Hospital

Glasgow, , G81 4DY

Barts Health NHS Trust, London, United Kingdom

Status

Withdrawn

Address

Barts Health NHS Trust

London, , EC1A 7BE

Royal Free Hospital, London, United Kingdom

Status

Completed

Address

Royal Free Hospital

London, , NW3 2QG

Royal Brompton Hospital, London, United Kingdom

Status

Withdrawn

Address

Royal Brompton Hospital

London, , SW3 6NP

Hammersmith Hospital, London, United Kingdom

Status

Completed

Address

Hammersmith Hospital

London, , W12 0HS

Freeman Hospital, Newcastle Upon Tyne, United Kingdom

Status

Withdrawn

Address

Freeman Hospital

Newcastle Upon Tyne, , NE7 7DN

Sheffield, United Kingdom

Status

Completed

Address

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Sheffield, , S10 2RX

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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