Hypertension, PulmonaryEarly Phase 1CIPHERNCT04193046
A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)
A Early Phase 1 study testing Blood Sample in people with Hypertension, Pulmonary, run by Janssen Research & Development, LLC at 49 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Blood Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 907 participants
- Where
- 49 sitesin 9 countries
- Study dates
- 16 Dec 2019to 18 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 (%)
Trial locations and contacts
49 sites in 9 countries.
49 sites in 9 countries
United States16 sites
University Of Colorado Cardiac And Vascular Center
Aurora, Colorado, 80045-2548
Tufts Medical Center
Boston, Massachusetts, 02111-1552
University of Cincinnati
Cincinnati, Ohio, 45267
UT Southwestern Medical Center
Dallas, Texas, 75390-8550
The Houston Methodist Research Institute
Houston, Texas, 77030
University Of Iowa - Hospitals & Clinics
Iowa City, Iowa, 52242
Ascension St. Vincent's Lung Institute
Jacksonville, Florida, 32204
Mayo Clinic
Jacksonville, Florida, 32224
Pulmonary Health Physicians, PC
Liverpool, New York, 13088
University of Southern California
Los Angeles, California, 90033
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
LSU Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5990
Pulmonary Associates Of Richmond
Richmond, Virginia, 23230
Mayo Clinic
Rochester, Minnesota, 55905
Germany7 sites
Universitatsklinikum Bonn
Bonn, 53105
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
Dresden, 01307
Universitaetsklinikum Giessen
Giessen, 35392
Thoraxklinik Heidelberg
Heidelberg, 69126
Lungenfachklinik Immenhausen
Immenhaus, 34376
Universitätsklinikum Jena Klinik für Innere Medizin I
Jena, 07747
Universitatsklinikum Schleswig Holstein
Lübeck, 23538
Spain6 sites
Hosp Univ Vall D Hebron
Barcelona, 8035
Hosp Clinic de Barcelona
Barcelona, 8036
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp Clinico Univ de Salamanca
Salamanca, 37008
Hosp. Univ. Marques de Valdecilla
Santander, 39008
Hosp. Virgen de La Salud
Toledo, 45004
France5 sites
CHU de Brest - Hopital de la Cavale Blanche
Brest, 29200
Hopital de Bicetre
Le Kremlin-Bicêtre, 94270
Hôpital Cardiologique - Chru Lille
Lille, 59037
CHU de Montpellier - Arnaud de Villeneuve
Montpellier, 34295
Hopital Larrey CHU de Toulouse
Toulouse, 31059
United Kingdom5 sites
Royal United Hospital
Bath, BA1 3NG
National Waiting Times Centre Board Golden Jubilee National Hospital
Glasgow, G81 4DY
Royal Free Hospital
London, NW3 2QG
Hammersmith Hospital
London, W12 0HS
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, S10 2RX
Ukraine4 sites
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
Cherkasy, 18009
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
Dnipro, 49070
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, 02000
SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
Kyiv, 03038
Poland3 sites
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego
Lublin, 20 718
Europejskie Centrum Zdrowia Otwock Sp z o o
Otwock, 05 400
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
Szczecin, 70-111
Belgium2 sites
ULB Erasme Ziekenhuis
Brussels, 1070
UZ Leuven Gasthuisberg
Leuven, 3000
About this study
Official title: A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)
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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Blood Sample
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with PH and non-PH | Other | 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. Receives: Other: Blood Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start16 Dec 2019
- Primary completion20 Dec 2021
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193046
- Sponsor's protocol ID
- CR108723
- Other IDs
- NAPUH0001
- Acronym
- CIPHER
- Status last verified
- Sep 2025
- First submitted
- 6 Dec 2019
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH)
- ClinicalTrials.gov ID
- NCT04193046
- Acronym / sponsor ID
- CIPHER / CR108723
- Conditions
- Hypertension, Pulmonary
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with PH and non-PH | Other | Other: Blood SampleBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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 (%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SamplePrevalent (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. | Other | Participants with PH and non-PH |
Primary outcome
Expression Levels of miRNAs Biomarkers
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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
Time frame: Day 1
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.
2 secondary outcomes
Area Under ROC Curve in Participants with PH who are Receiving Therapies Versus not Receiving drug Therapy
Time frame: Day 1
Area Under ROC Curve in Participants with PAH, CTEPH, Isolated pre-Capillary and post-Capillary PH
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Hypertension, Pulmonary
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
49 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Blood Sample in people with Hypertension, Pulmonary, run by Janssen Research & Development, LLC at 49 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Germany, Spain, France, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression Levels of miRNAs Biomarkers (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.