Pulmonary HypertensionNCT07647549
Pulmonary Hypertension (PH) Biorepository for Translational Research
An observational study of Pulmonary Hypertension, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
Trial summary
Background: Pulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 1,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Oct 2026to 1 Jun 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult male and female participants older than 18 years who are suspected of having or have been diagnosed with pulmonary hypertension (PH). Eligible individuals must be able to understand the study requirements and be willing to provide written informed consent by signing and dating the informed consent form prior to participation.
Who may be able to join
- Provision of signed and dated informed consent form
- Males and females aged >=18 years old
- Suspected of or diagnosed with PH
- Able to understand and willing to sign a written informed consent document
Who cannot join
- Any individual who does not meet all inclusion criteria or is deemed by the local investigator not to be a blood draw candidate will be excluded from participating in this study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Maryland Medical Center at Baltimore (UMB)
Baltimore, Maryland, 21201
Gautam Ramani, Not Listed, gramani@medicine.umaryland.edu
Bradley Maron, Not Listed, BMaron@som.umaryland.edu
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
- Not yet recruiting
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Background:
Pulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. They hope to use this information to find better ways to diagnose and treat PH.
Read more
Objective:
To collect blood samples and health information from people suspected of or diagnosed with PH.
Eligibility:
People aged 18 years and older who have or may have PH.
Design:
Researchers will collect information from participants medical records.
Participants will have blood drawn from a vein. About 3 tablespoons will be collected during the study visit. The visit will last about 1 hour.
Participants may choose to provide new blood samples at follow-up visits. Updated medical information may also be collected.
Participants may continue to participate as long as the study is ongoing. Participants may opt out of providing new blood samples but remain in the study.
All study samples will be stored at the National Institutes of Health. Health information will be stored in secure databases.
Read the detailed description
Study Description:
This study aims to establish a biorepository based on the World Symposium Pulmonary Hypertension (PH) Groups 1-5. In the future, IRB approved protocols may use these blood samples to discover novel, biologically relevant, non-invasive PH biomarkers. In combination with clinical data these potential biomarkers will be used to distinguish PH groups, elucidate underlying molecular phenotypes, predict clinically relevant outcomes, as well as discriminate healthy (healthy subjects will not be enrolled under this protocol) from PH disease states, and differentiate patients with PH from patients without PH. To this end, multimodal genomic, metabolomic, and proteomic assays will eventually be developed and used.
Objectives:
Primary:
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
Secondary:
Collect the specific data attributes that may be used in the future to determine whether multimodal genomic, metabolomic or proteomic biomarkers, in combination with clinical data, can:
-Elucidate molecular phenotypes that distinguish between patients across PH groups
Predict clinically relevant outcomes (i.e., disease severity, disease progression, response to therapy, transplant free survival).
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Biorepository
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (suspected of or diagnosed) | Pulmonary Arterial Hypertension, PAH | |
| Group 2 (suspected of or diagnosed) | PH due to left heart disease | |
| Group 3 (suspected of or diagnosed) | PH due to lung diseases and/or hypoxia | |
| Group 4 (suspected of or diagnosed) | PH due to thromboembolic disease | |
| Group 5 (suspected of or diagnosed) | PH with unclear or multifactorial mechanisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a multi-center biorepository.
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
Measured: 10 years
Secondary outcomes (1)
Collect the specific data attributes in combination with clinical data to be used in the future to determine multimodal genomic, metabolomic or proteomic biomarkers.
This research may predict clinically relevant outcomes. Elucidate molecular phenotypes that distinguish between patients across PH groups
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start19 Oct 2026
- Primary completion1 Jun 2036 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael A Solomon, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647549
- Sponsor's protocol ID
- 10002634
- Other IDs
- 002634-CC
- Status last verified
- 20 Oct 2026
- First submitted
- 12 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.
PubMed 26771485Lehmann-Werman R, Neiman D, Zemmour H, Moss J, Magenheim J, Vaknin-Dembinsky A, Rubertsson S, Nellgard B, Blennow K, Zetterberg H, Spalding K, Haller MJ, Wasserfall CH, Schatz DA, Greenbaum CJ, Dorrell C, Grompe M, Zick A, Hubert A, Maoz M, Fendrich V, Bartsch DK, Golan T, Ben Sasson SA, Zamir G, Razin A, Cedar H, Shapiro AM, Glaser B, Shemer R, Dor Y. Identification of tissue-specific cell death using methylation patterns of circulating DNA. Proc Natl Acad Sci U S A. 2016 Mar 29;113(13):E1826-34. doi: 10.1073/pnas.1519286113. Epub 2016 Mar 14.
PubMed 26976580Corcoran RB, Chabner BA. Application of Cell-free DNA Analysis to Cancer Treatment. N Engl J Med. 2018 Nov 1;379(18):1754-1765. doi: 10.1056/NEJMra1706174. No abstract available.
PubMed 30380390Agbor-Enoh S, Tunc I, De Vlaminck I, Fideli U, Davis A, Cuttin K, Bhatti K, Marishta A, Solomon MA, Jackson A, Graninger G, Harper B, Luikart H, Wylie J, Wang X, Berry G, Marboe C, Khush K, Zhu J, Valantine H. Applying rigor and reproducibility standards to assay donor-derived cell-free DNA as a non-invasive method for detection of acute rejection and graft injury after heart transplantation. J Heart Lung Transplant. 2017 Sep;36(9):1004-1012. doi: 10.1016/j.healun.2017.05.026. Epub 2017 May 20.
PubMed 28624139Agbor-Enoh S, Jackson AM, Tunc I, Berry GJ, Cochrane A, Grimm D, Davis A, Shah P, Brown AW, Wang Y, Timofte I, Shah P, Gorham S, Wylie J, Goodwin N, Jang MK, Marishta A, Bhatti K, Fideli U, Yang Y, Luikart H, Cao Z, Pirooznia M, Zhu J, Marboe C, Iacono A, Nathan SD, Orens J, Valantine HA, Khush K. Late manifestation of alloantibody-associated injury and clinical pulmonary antibody-mediated rejection: Evidence from cell-free DNA analysis. J Heart Lung Transplant. 2018 Jul;37(7):925-932. doi: 10.1016/j.healun.2018.01.1305. Epub 2018 Jan 31.
PubMed 29500138Polina IA, Ilatovskaya DV, DeLeon-Pennell KY. Cell free DNA as a diagnostic and prognostic marker for cardiovascular diseases. Clin Chim Acta. 2020 Apr;503:145-150. doi: 10.1016/j.cca.2020.01.013. Epub 2020 Jan 21.
PubMed 31978408Abiose AK, Mansoor GA, Barry M, Soucier R, Nair CK, Hager D. Effect of spironolactone on endothelial function in patients with congestive heart failure on conventional medical therapy. Am J Cardiol. 2004 Jun 15;93(12):1564-6. doi: 10.1016/j.amjcard.2004.03.015.
PubMed 15194040Maron BA. Revised Definition of Pulmonary Hypertension and Approach to Management: A Clinical Primer. J Am Heart Assoc. 2023 Apr 18;12(8):e029024. doi: 10.1161/JAHA.122.029024. Epub 2023 Apr 7.
PubMed 37026538Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
PubMed 30545968Kovacs G, Bartolome S, Denton CP, Gatzoulis MA, Gu S, Khanna D, Badesch D, Montani D. Definition, classification and diagnosis of pulmonary hypertension. Eur Respir J. 2024 Oct 31;64(4):2401324. doi: 10.1183/13993003.01324-2024. Print 2024 Oct.
PubMed 39209475Zemmour H, Planer D, Magenheim J, Moss J, Neiman D, Gilon D, Korach A, Glaser B, Shemer R, Landesberg G, Dor Y. Non-invasive detection of human cardiomyocyte death using methylation patterns of circulating DNA. Nat Commun. 2018 Apr 24;9(1):1443. doi: 10.1038/s41467-018-03961-y.
PubMed 29691397Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE, Krueger KE, Rom W, Sanda M, Sorbara L, Stass S, Wang W, Brenner DE. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009 Jan;8(1):113-7. doi: 10.1021/pr800545q.
PubMed 19072545
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension (PH) Biorepository for Translational Research
- ClinicalTrials.gov ID
- NCT07647549
- Acronym / sponsor ID
- 10002634
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Biorepository
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 1 Jun 2036 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 15 Jun 2026 (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.
Background:
Pulmonary hypertension (PH) is high blood pressure in the blood vessels of the lungs. It can lead to heart failure and death if not treated. Researchers want to create a repository of blood samples and health information collected from people with PH. They hope to use this information to find better ways to diagnose and treat PH.
Objective:
To collect blood samples and health information from people suspected of or diagnosed with PH.
Eligibility:
People aged 18 years and older who have or may have PH.
Design:
Researchers will collect information from participants medical records.
Participants will have blood drawn from a vein. About 3 tablespoons will be collected during the study visit. The visit will last about 1 hour.
Participants may choose to provide new blood samples at follow-up visits. Updated medical information may also be collected.
Participants may continue to participate as long as the study is ongoing. Participants may opt out of providing new blood samples but remain in the study.
All study samples will be stored at the National Institutes of Health. Health information will be stored in secure databases.
Detailed description
Study Description:
This study aims to establish a biorepository based on the World Symposium Pulmonary Hypertension (PH) Groups 1-5. In the future, IRB approved protocols may use these blood samples to discover novel, biologically relevant, non-invasive PH biomarkers. In combination with clinical data these potential biomarkers will be used to distinguish PH groups, elucidate underlying molecular phenotypes, predict clinically relevant outcomes, as well as discriminate healthy (healthy subjects will not be enrolled under this protocol) from PH disease states, and differentiate patients with PH from patients without PH. To this end, multimodal genomic, metabolomic, and proteomic assays will eventually be developed and used.
Objectives:
Primary:
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
Secondary:
Collect the specific data attributes that may be used in the future to determine whether multimodal genomic, metabolomic or proteomic biomarkers, in combination with clinical data, can:
-Elucidate molecular phenotypes that distinguish between patients across PH groups
Predict clinically relevant outcomes (i.e., disease severity, disease progression, response to therapy, transplant free survival).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 (suspected of or diagnosed) | – | –Pulmonary Arterial Hypertension, PAH |
| Group 2 (suspected of or diagnosed) | – | –PH due to left heart disease |
| Group 3 (suspected of or diagnosed) | – | –PH due to lung diseases and/or hypoxia |
| Group 4 (suspected of or diagnosed) | – | –PH due to thromboembolic disease |
| Group 5 (suspected of or diagnosed) | – | –PH with unclear or multifactorial mechanisms |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult male and female participants older than 18 years who are suspected of having or have been diagnosed with pulmonary hypertension (PH). Eligible individuals must be able to understand the study requirements and be willing to provide written informed consent by signing and dating the informed consent form prior to participation.
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Males and females aged >=18 years old
- Suspected of or diagnosed with PH
- Able to understand and willing to sign a written informed consent document
Key exclusion criteria (1 listed)
- Any individual who does not meet all inclusion criteria or is deemed by the local investigator not to be a blood draw candidate will be excluded from participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a multi-center biorepository.
Time frame: 10 years
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
1 secondary outcome
Collect the specific data attributes in combination with clinical data to be used in the future to determine multimodal genomic, metabolomic or proteomic biomarkers.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 26771485Snyder MW, Kircher M, Hill AJ, Daza RM, Shendure J. Cell-free DNA Comprises an In Vivo Nucleosome Footprint that Informs Its Tissues-Of-Origin. Cell. 2016 Jan 14;164(1-2):57-68. doi: 10.1016/j.cell.2015.11.050.
- Background: PubMed 26976580Lehmann-Werman R, Neiman D, Zemmour H, Moss J, Magenheim J, Vaknin-Dembinsky A, Rubertsson S, Nellgard B, Blennow K, Zetterberg H, Spalding K, Haller MJ, Wasserfall CH, Schatz DA, Greenbaum CJ, Dorrell C, Grompe M, Zick A, Hubert A, Maoz M, Fendrich V, Bartsch DK, Golan T, Ben Sasson SA, Zamir G, Razin A, Cedar H, Shapiro AM, Glaser B, Shemer R, Dor Y. Identification of tissue-specific cell death using methylation patterns of circulating DNA. Proc Natl Acad Sci U S A. 2016 Mar 29;113(13):E1826-34. doi: 10.1073/pnas.1519286113. Epub 2016 Mar 14.
- Background: PubMed 30380390Corcoran RB, Chabner BA. Application of Cell-free DNA Analysis to Cancer Treatment. N Engl J Med. 2018 Nov 1;379(18):1754-1765. doi: 10.1056/NEJMra1706174. No abstract available.
- Background: PubMed 28624139Agbor-Enoh S, Tunc I, De Vlaminck I, Fideli U, Davis A, Cuttin K, Bhatti K, Marishta A, Solomon MA, Jackson A, Graninger G, Harper B, Luikart H, Wylie J, Wang X, Berry G, Marboe C, Khush K, Zhu J, Valantine H. Applying rigor and reproducibility standards to assay donor-derived cell-free DNA as a non-invasive method for detection of acute rejection and graft injury after heart transplantation. J Heart Lung Transplant. 2017 Sep;36(9):1004-1012. doi: 10.1016/j.healun.2017.05.026. Epub 2017 May 20.
- Background: PubMed 29500138Agbor-Enoh S, Jackson AM, Tunc I, Berry GJ, Cochrane A, Grimm D, Davis A, Shah P, Brown AW, Wang Y, Timofte I, Shah P, Gorham S, Wylie J, Goodwin N, Jang MK, Marishta A, Bhatti K, Fideli U, Yang Y, Luikart H, Cao Z, Pirooznia M, Zhu J, Marboe C, Iacono A, Nathan SD, Orens J, Valantine HA, Khush K. Late manifestation of alloantibody-associated injury and clinical pulmonary antibody-mediated rejection: Evidence from cell-free DNA analysis. J Heart Lung Transplant. 2018 Jul;37(7):925-932. doi: 10.1016/j.healun.2018.01.1305. Epub 2018 Jan 31.
- Background: PubMed 31978408Polina IA, Ilatovskaya DV, DeLeon-Pennell KY. Cell free DNA as a diagnostic and prognostic marker for cardiovascular diseases. Clin Chim Acta. 2020 Apr;503:145-150. doi: 10.1016/j.cca.2020.01.013. Epub 2020 Jan 21.
- Background: PubMed 15194040Abiose AK, Mansoor GA, Barry M, Soucier R, Nair CK, Hager D. Effect of spironolactone on endothelial function in patients with congestive heart failure on conventional medical therapy. Am J Cardiol. 2004 Jun 15;93(12):1564-6. doi: 10.1016/j.amjcard.2004.03.015.
- Background: PubMed 37026538Maron BA. Revised Definition of Pulmonary Hypertension and Approach to Management: A Clinical Primer. J Am Heart Assoc. 2023 Apr 18;12(8):e029024. doi: 10.1161/JAHA.122.029024. Epub 2023 Apr 7.
- Background: PubMed 30545968Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
- Background: PubMed 39209475Kovacs G, Bartolome S, Denton CP, Gatzoulis MA, Gu S, Khanna D, Badesch D, Montani D. Definition, classification and diagnosis of pulmonary hypertension. Eur Respir J. 2024 Oct 31;64(4):2401324. doi: 10.1183/13993003.01324-2024. Print 2024 Oct.
- Background: PubMed 29691397Zemmour H, Planer D, Magenheim J, Moss J, Neiman D, Gilon D, Korach A, Glaser B, Shemer R, Landesberg G, Dor Y. Non-invasive detection of human cardiomyocyte death using methylation patterns of circulating DNA. Nat Commun. 2018 Apr 24;9(1):1443. doi: 10.1038/s41467-018-03961-y.
- Background: PubMed 19072545Tuck MK, Chan DW, Chia D, Godwin AK, Grizzle WE, Krueger KE, Rom W, Sanda M, Sorbara L, Stass S, Wang W, Brenner DE. Standard operating procedures for serum and plasma collection: early detection research network consensus statement standard operating procedure integration working group. J Proteome Res. 2009 Jan;8(1):113-7. doi: 10.1021/pr800545q.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Michael A Solomon, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Solomon, M.D. ((301) 496-9320, msolomon@cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a multi-center biorepository. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07647549, which also lists 12 linked publications.
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 22 Oct 2026.