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A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH) (CIPHER)

Primary Purpose

Hypertension, Pulmonary

Status
Completed
Phase
Early Phase 1
Locations
International
Study Type
Interventional
Intervention
Blood Sample
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories
  • 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 provide an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [DNA]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study

Exclusion Criteria:

  • Participants requiring renal dialysis
  • History of lung or heart transplant (waiting list status or consideration of enlisting is allowed)
  • Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)

Sites / Locations

  • University of Southern California
  • University Of Colorado Cardiac And Vascular Center
  • Ascension St. Vincent's Lung Institute
  • Mayo Clinic
  • University Of Iowa - Hospitals & Clinics
  • Norton Pulmonary Specialists
  • LSU Health Sciences Center New Orleans
  • Tufts Medical Center
  • Mayo Clinic
  • University of Nebraska Medical Center
  • Pulmonary Health Physicians, PC
  • Icahn School of Medicine at Mount Sinai
  • University of Cincinnati
  • UT Southwestern Medical Center
  • The Houston Methodist Research Institute
  • Pulmonary Associates Of Richmond
  • ULB Erasme Ziekenhuis
  • UZ Leuven Gasthuisberg
  • CHU de Brest - Hôpital de la Cavale Blanche
  • Hopital de Bicetre
  • Hôpital Cardiologique - Chru Lille
  • CHU de Montpellier - Arnaud de Villeneuve
  • Hopital Larrey CHU de Toulouse
  • Universitatsklinikum Bonn
  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
  • Universitaetsklinikum Giessen
  • Thoraxklinik Heidelberg
  • Lungenfachklinik Immenhausen
  • Universitätsklinikum Jena Klinik für Innere Medizin I
  • Universitätsklinikum Schleswig-Holstein
  • VUMC Amsterdam
  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
  • Europejskie Centrum Zdrowia Otwock Sp. z o.o
  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
  • Hosp. Univ. Vall D Hebron
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. 12 de Octubre
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Virgen de La Salud
  • CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
  • CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
  • Royal United Hospital
  • National Waiting Times Centre Board Golden Jubilee National Hospital
  • Royal Free Hospital
  • Hammersmith Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Participants with PH and non-PH

Arm Description

Blood samples will be collected for biomarker analysis from new (incident) and existing (prevalent) participants who undergo right heart catheterization (RHC). Participants will be categorized into non-PH or PH based on the results of the RHC and those who are found to have PH will be further classified into the different groups of PH. A transthoracic echocardiography (TTE) will be performed if not done previously.

Outcomes

Primary Outcome Measures

Expression Levels of miRNAs Biomarkers
Blood samples will be collected for micro Ribonucleic acid (miRNA) assay by qPCR to identify a biomarker signature for the early detection of pulmonary hypertension (PH).
Biomarker signatures for miRNA
Blood will be collected for miRNA to identify a biomarker signature(s) for detection of participants at high risk of PH.
Biomarker Signature Performance in Identifying Participants with PH
Biomarker signature performance will be evaluated by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the biomarker signatures documented by RHC for identifying participants with PH.
Comparison of Performance of Biomarker Signatures and Transthoracic Echocardiogram (TTE) Based on Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value
The performance of the biomarkers signatures will be compared to the performance of TTE to identify participants with PH documented by RHC via sensitivity, specificity, positive predictive value, and negative predictive value. The sensitivity/specificity of the tests will be compared using McNemar's test.

Secondary Outcome Measures

Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy
Performance of the biomarker signatures will be assessed using ROC curve in participants with PH who are receiving pulmonary arterial hypertension-specific drug therapies versus participants who are not receiving any drug therapy.
Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH
Performance of the biomarker signatures will be assessed using ROC curve in participants with pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), isolated pre-capillary and post-capillary PH.

Full Information

First Posted
December 6, 2019
Last Updated
April 20, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04193046
Brief Title
A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
Acronym
CIPHER
Official Title
A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
February 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
908 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with PH and non-PH
Arm Type
Other
Arm Description
Blood samples will be collected for biomarker analysis from new (incident) and existing (prevalent) participants who undergo right heart catheterization (RHC). Participants will be categorized into non-PH or PH based on the results of the RHC and those who are found to have PH will be further classified into the different groups of PH. A transthoracic echocardiography (TTE) will be performed if not done previously.
Intervention Type
Other
Intervention Name(s)
Blood Sample
Intervention Description
Prevalent (existing) and incident (new) participants who are found to either have PH or not by RHC will provide blood sample for the establishment of a biomarker signature of PH.
Primary Outcome Measure Information:
Title
Expression Levels of miRNAs Biomarkers
Description
Blood samples will be collected for micro Ribonucleic acid (miRNA) assay by qPCR to identify a biomarker signature for the early detection of pulmonary hypertension (PH).
Time Frame
Day 1
Title
Biomarker signatures for miRNA
Description
Blood will be collected for miRNA to identify a biomarker signature(s) for detection of participants at high risk of PH.
Time Frame
Day 1
Title
Biomarker Signature Performance in Identifying Participants with PH
Description
Biomarker signature performance will be evaluated by estimating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the biomarker signatures documented by RHC for identifying participants with PH.
Time Frame
Day 1
Title
Comparison of Performance of Biomarker Signatures and Transthoracic Echocardiogram (TTE) Based on Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value
Description
The performance of the biomarkers signatures will be compared to the performance of TTE to identify participants with PH documented by RHC via sensitivity, specificity, positive predictive value, and negative predictive value. The sensitivity/specificity of the tests will be compared using McNemar's test.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy
Description
Performance of the biomarker signatures will be assessed using ROC curve in participants with PH who are receiving pulmonary arterial hypertension-specific drug therapies versus participants who are not receiving any drug therapy.
Time Frame
Day 1
Title
Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH
Description
Performance of the biomarker signatures will be assessed using ROC curve in participants with pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), isolated pre-capillary and post-capillary PH.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having undergone an right heart catheterization (RHC) within 18 months (prevalent PH participants) or 6 months (prevalent non-PH participants) or have undergone or planned RHC within 6 weeks (incident participants). The results of the incident RHC (incident participants) or the most recent RHC (prevalent participants) will be used to classify the participant in one of the above study population categories 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 provide an Informed Consent Form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study Must provide a separate informed consent (or their legally-acceptable representative must sign) if he or she agrees to provide an optional (deoxyribonucleic acid [DNA]) sample for research (where local regulations permit). Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study Exclusion Criteria: Participants requiring renal dialysis History of lung or heart transplant (waiting list status or consideration of enlisting is allowed) Severe left ventricular dysfunction: Left ventricular ejection function less then (<) 35 percent (%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University Of Colorado Cardiac And Vascular Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-2548
Country
United States
Facility Name
Ascension St. Vincent's Lung Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University Of Iowa - Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Norton Pulmonary Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5990
Country
United States
Facility Name
Pulmonary Health Physicians, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8550
Country
United States
Facility Name
The Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pulmonary Associates Of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
ULB Erasme Ziekenhuis
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Brest - Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hopital de Bicetre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Hôpital Cardiologique - Chru Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Montpellier - Arnaud de Villeneuve
City
MONTPELLIER Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Larrey CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhaus
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitätsklinikum Jena Klinik für Innere Medizin I
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
VUMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1007 MB
Country
Netherlands
Facility Name
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28051
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37008
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Virgen de La Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
City
Dnipro
ZIP/Postal Code
49070
Country
Ukraine
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
02000
Country
Ukraine
Facility Name
SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
City
Kyiv
ZIP/Postal Code
03038
Country
Ukraine
Facility Name
Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
National Waiting Times Centre Board Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)

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