Pulmonary Hypertension (PH) Biorepository for Translational Research

Обзор

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.

Подробное описание

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).

Первичные конечные точки

• Develop a multi-center biorepository. [Срок оценки: 10 years]

Вторичные конечные точки (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. [Срок оценки: 10 years]

Критерии участия

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• University of Maryland Medical Center at Baltimore (UMB) — Baltimore
• National Institutes of Health Clinical Center — Bethesda
• INOVA Fairfax Hospital — Falls Church

Публикации

• 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
• 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 PMID 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. PMID 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 He PMID 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 rejecti PMID 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. PMID 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. PMID 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. PMID 37026538

Идентификаторы

NCT: NCT07647549 · 10002634 · 002634-CC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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