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

Sponsor
Actelion (Industry)
Overall Status
Completed
CT.gov ID
NCT04480723
Collaborator
(none)
86
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Sample
  • Diagnostic Test: Cardiac MRI
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Dec 11, 2020
Actual Primary Completion Date :
May 13, 2022
Actual Study Completion Date :
May 18, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitatsklinikum Bonn Bonn Germany 53105
2 Universitaetsklinikum Giessen Giessen Germany 35392
3 Universitätsklinikum Schleswig-Holstein Luebeck Germany 23538
4 Royal United Hospital Bath United Kingdom BA1 3NG
5 National Waiting Times Centre Board Golden Jubilee National Hospital Glasgow United Kingdom G81 4DY
6 Royal Free Hospital London United Kingdom NW3 2QG
7 Hammersmith Hospital London United Kingdom W12 0HS
8 Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital Sheffield United Kingdom S10 2RX

Sponsors and Collaborators

  • Actelion

Investigators

  • Study Director: Actelion Clinical Trial, Actelion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Actelion
ClinicalTrials.gov Identifier:
NCT04480723
Other Study ID Numbers:
  • CR108827
  • NAPUH0003
First Posted:
Jul 21, 2020
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022