Pulmonary Hypertension (PH) Biorepository for Translational Research
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael A Solomon, M.D.
- Número de teléfono: (301) 496-9320
- Correo electrónico: msolomon@cc.nih.gov
Ubicaciones de estudio
-
-
Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland Medical Center at Baltimore (UMB)
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Contacto:
- Gautam Ramani
- Número de teléfono: Not Listed
- Correo electrónico: gramani@medicine.umaryland.edu
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Contacto:
- Bradley Maron
- Número de teléfono: Not Listed
- Correo electrónico: BMaron@som.umaryland.edu
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Bethesda, Maryland, Estados Unidos, 20892
- National Institutes of Health Clinical Center
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Contacto:
- NIH Clinical Center Office of Patient Recruitment (OPR)
- Número de teléfono: TTY dial 711 800-411-1222
- Correo electrónico: ccopr@nih.gov
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042
- INOVA Fairfax Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Develop a multi-center biorepository.
Periodo de tiempo: 10 years
|
Develop a multi-center biorepository of patients suspected of or diagnosed with PH Group 1-5.
|
10 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Collect the specific data attributes in combination with clinical data to be used in the future to determine multimodal genomic, metabolomic or proteomic biomarkers.
Periodo de tiempo: 10 years
|
This research may predict clinically relevant outcomes.
Elucidate molecular phenotypes that distinguish between patients across PH groups
|
10 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael A Solomon, M.D., National Institutes of Health Clinical Center (CC)
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10002634
- 002634-CC
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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Criterios de acceso compartido de IPD
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- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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