Pulmonary Hypertension (PH) Biorepository for Translational Research

NCT07647549 | Not Yet Recruiting

• 2 other identifiers: 10002634002634-CC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Develop a multi-center biorepository.

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

  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.

  10 years

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (3)

University of Maryland Medical Center (UMMC) at Baltimore

Baltimore, Maryland, 21201, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

INOVA Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Related Publications (12)

• 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.

  PMID: 26771485 BACKGROUND

• 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.

  PMID: 26976580 BACKGROUND

• 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.

  PMID: 30380390 BACKGROUND

• 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.

  PMID: 28624139 BACKGROUND

• 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.

  PMID: 29500138 BACKGROUND

• 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.

  PMID: 31978408 BACKGROUND

• 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.

  PMID: 15194040 BACKGROUND

• 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.

  PMID: 37026538 BACKGROUND

• 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.

  PMID: 30545968 BACKGROUND

• 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.

  PMID: 39209475 BACKGROUND

• 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.

  PMID: 29691397 BACKGROUND

• 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.

  PMID: 19072545 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michael A Solomon, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Solomon, M.D.

CONTACT

(301) 496-9320; msolomon@cc.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2036
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 12 months from publication
• Access Criteria: Published IPD will be shared upon request to the research team.

Locations

US (3)