ClinicalTrials.gg
RecruitingNCT07647549Updated Oct 22, 2026

Pulmonary Hypertension (PH) Biorepository for Translational Research

An observational study in Pulmonary Hypertension, sponsored by National Institutes of Health Clinical Center (CC). Recruiting at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Updated Oct 22, 2026Now RecruitingStart date moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 397 studies in Hypertension, Pulmonary with a site in United States — 73 open to participants now, 87 under way, 9 of them phase 3. Hypertension, Pulmonary · United States.

Planned enrollment
16th of 107
1,000 · median 108
Started
2026
with 23 others
Observational
109 of 397
29 open now
Primary completion
2036-06
later than 83 of 85 live
Registered
391st of 397
by date

Among the 397 studies in Hypertension, Pulmonary with a site in United States, this one is the 16th largest by planned enrollment of the 107 observational ones that give a count, is one of 24 that started in 2026, is one of 109 observational ones, reaches primary completion later than 83 of the 85 other live ones, and was the 391st registered.

Hypertension, Pulmonary

1,091 studies on the registry are indexed under Hypertension, Pulmonary; 243 are open to participants now.

Browse Hypertension, Pulmonary studies →

Open to participants now

73 of the 397 studies in Hypertension, Pulmonary with a site in United States are open now. Recruiting first, the newest first:

67 more — sign in →

All 73 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 163 Hypertension, Pulmonary studies recruiting now, 99 (61%) set no upper age limit and 26 (16%) stop at 75 or younger; 39 take children under 18; 24 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 397 studies in Hypertension, Pulmonary with a site in United States, or all of them as a file.
02

Study 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. 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.

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).

03

Conditions studied

  • Pulmonary Hypertension

Keywords

  • Pulmonary Hypertension
  • Biorepository
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of signed and dated 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

Exclusion criteria

EXCLUSION CRITERIA:

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Develop a multi-center biorepository.

    Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.

    Time frame: 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

    Time frame: 10 years

07

Study locations

1 of 3 sites recruiting
08

References and documents

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 26771485 ↗
  • Lehmann-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 26976580 ↗
  • Corcoran 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 30380390 ↗
  • Agbor-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 28624139 ↗
  • Agbor-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 29500138 ↗
  • Polina 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 31978408 ↗
  • Abiose 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 15194040 ↗
  • Maron 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 37026538 ↗
  • Simonneau 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 30545968 ↗
  • Kovacs 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 39209475 ↗
  • Zemmour 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 29691397 ↗
  • Tuck 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 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol

Time frame: Within 12 months from publication

Access criteria: Published IPD will be shared upon request to the research team.

09

Timeline

19 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Jun 2036, 115 months after the start.

Of 142 non-industry observational studies under Hypertension, Pulmonary, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 167. This study's planned 115 months is above that.

Counting every sponsor, half of 167 studies reached it within 59 months; a quarter within 24 and three quarters within 107.

Start moved 19 times since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, last on Oct 22, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2026
First posted
Jun 15, 2026
StartActual
Oct 19, 2026was Sep 2026
Primary completionEst.
Jun 1, 2036
CompletionEst.
Jun 1, 2036
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 21, 2026
Sites
3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
Show 3 sites
  • University of Maryland Medical Center at Baltimore (UMB) · Baltimore, United Statesno status→Not yet recruiting
  • National Institutes of Health Clinical Center · Bethesda, United Statesno status→Recruiting
  • INOVA Fairfax Hospital · Falls Church, United Statesno status→Not yet recruiting
Oct 21, 2026
Start date
Sep 29, 2026→Oct 19, 2026 (actual)
moved 19 times, Sep 25, 2026 – Oct 22, 2026
Show all 19 updates
  1. Oct 22, 2026
    Start date Oct 26, 2026→Oct 19, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 21, 2026
    Not yet recruiting→Recruiting
    3 sites changed recruiting status (2 now not yet recruiting, 1 now recruiting)
    Show 3 sites
    • University of Maryland Medical Center at Baltimore (UMB) · Baltimore, United Statesno status→Not yet recruiting
    • National Institutes of Health Clinical Center · Bethesda, United Statesno status→Recruiting
    • INOVA Fairfax Hospital · Falls Church, United Statesno status→Not yet recruiting
    Start date Oct 25, 2026→Oct 26, 2026
    + 2 other changes: verification date and references
  3. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  4. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
  5. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  6. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  7. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  8. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  9. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  10. Oct 8, 2026
    Start date Oct 12, 2026→Oct 13, 2026
  11. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
  12. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  13. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  14. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  15. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  16. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
  17. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
  18. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  19. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07647549
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Oct 19, 2026
Primary completion
Jun 1, 2036 (estimated)
Completion
Jun 1, 2036 (estimated)
Last update
Oct 22, 2026

Study contacts

Michael A Solomon, M.D.
Contact
msolomon@cc.nih.gov
(301) 496-9320
Michael A Solomon, M.D.
principal investigator · National Institutes of Health Clinical Center (CC)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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