Pulmonary Hypertension (PH) Biorepository for Translational Research
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).
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Michael A Solomon, M.D.
- Numero di telefono: (301) 496-9320
- Email: msolomon@cc.nih.gov
Luoghi di studio
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland Medical Center (UMMC) at Baltimore
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Bethesda, Maryland, Stati Uniti, 20892
- National Institutes of Health Clinical Center
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Contatto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Numero di telefono: TTY dial 711 800-411-1222
- Email: ccopr@nih.gov
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Virginia
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Falls Church, Virginia, Stati Uniti, 22042
- Inova Fairfax Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
- INCLUSION CRITERIA:
- 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
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
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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
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|
Group 4 (suspected of or diagnosed)
PH due to thromboembolic disease
|
|
Group 5 (suspected of or diagnosed)
PH with unclear or multifactorial mechanisms
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Develop a multi-center biorepository.
Lasso di tempo: 10 years
|
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
|
10 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Collect the specific data attributes in combination with clinical data to be used in the future to determine multimodal genomic, metabolomic or proteomic biomarkers.
Lasso di tempo: 10 years
|
This research may predict clinically relevant outcomes.
Elucidate molecular phenotypes that distinguish between patients across PH groups
|
10 years
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Michael A Solomon, M.D., National Institutes of Health Clinical Center (CC)
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Collegamenti utili
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10002634
- 002634-CC
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
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