Clinical trial NCT04241159 - References

Heart Failure — Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults

Citation(s)

•   Aging Well in the 21st Century: Strategic Directions for Research on Aging
  [cited 2018 8/10/18]; Available from: https://www.nia.nih.gov/about/aging-well-21st-century-strategic-directions-research-aging.
•   Bilder, G
  , Human biological aging : from macromolecules to organ-systems. 2016, Hoboken, New Jersey: Wiley Blackwell. ix, 330 pages.
•   Diane, S
  Common Terminology Criteria for Adverse Events. April 23, 2018; Available from: http://www.uptodate.com
•   Fresh Frozen Plasma: Indications and Risks: NIH Consensus Development Conference Statement
  1984 9/11/2018]; Available from: https://consensus.nih.gov/1984/1984FrozenPlasma045html.htm.
•   Hatse S, Brouwers B, Dalmasso B, Laenen A, Kenis C, Schöffski P, Wildiers H
  Circulating MicroRNAs as easy-to-measure aging biomarkers in older breast cancer patients: correlation with chronological age but not with fitness/frailty status. PLoS One. 2014 Oct 21;9(10):e110644. doi: 10.1371/journal.pone.0110644. eCollection 2014.
•   Hayflick L
  Biological aging is no longer an unsolved problem. Ann N Y Acad Sci. 2007 Apr;1100:1-13. Review.
•   Haykowsky MJ, Nicklas BJ, Brubaker PH, Hundley WG, Brinkley TE, Upadhya B, Becton JT, Nelson MD, Chen H, Kitzman DW
  Regional Adipose Distribution and its Relationship to Exercise Intolerance in Older Obese Patients Who Have Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2018 Aug;6(8):640-649. doi: 10.1016/j.jchf.2018.06.002. Epub 2018 Jul 11.
•   Haykowsky MJ, Tomczak CR, Scott JM, Paterson DI, Kitzman DW
  Determinants of exercise intolerance in patients with heart failure and reduced or preserved ejection fraction. J Appl Physiol (1985). 2015 Sep 15;119(6):739-44. doi: 10.1152/japplphysiol.00049.2015. Epub 2015 Apr 24. Review.
•   Hobart MP, Goldberg R, Bartko JJ, Gold JM
  Repeatable battery for the assessment of neuropsychological status as a screening test in schizophrenia, II: convergent/discriminant validity and diagnostic group comparisons. Am J Psychiatry. 1999 Dec;156(12):1951-7.
•   Justice JN, Ferrucci L, Newman AB, Aroda VR, Bahnson JL, Divers J, Espeland MA, Marcovina S, Pollak MN, Kritchevsky SB, Barzilai N, Kuchel GA
  A framework for selection of blood-based biomarkers for geroscience-guided clinical trials: report from the TAME Biomarkers Workgroup. Geroscience. 2018 Dec;40(5-6):419-436. doi: 10.1007/s11357-018-0042-y. Epub 2018 Aug 27. Review.
•   Kadota T, Fujita Y, Yoshioka Y, Araya J, Kuwano K, Ochiya T
  Emerging role of extracellular vesicles as a senescence-associated secretory phenotype: Insights into the pathophysiology of lung diseases. Mol Aspects Med. 2018 Apr;60:92-103. doi: 10.1016/j.mam.2017.11.005. Epub 2017 Nov 20. Review.
•   Katsimpardi L, Litterman NK, Schein PA, Miller CM, Loffredo FS, Wojtkiewicz GR, Chen JW, Lee RT, Wagers AJ, Rubin LL
  Vascular and neurogenic rejuvenation of the aging mouse brain by young systemic factors. Science. 2014 May 9;344(6184):630-4. doi: 10.1126/science.1251141. Epub 2014 May 5.
•   Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ
  Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
•   Kitzman DW, Brubaker PH, Morgan TM, Stewart KP, Little WC
  Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. 2010 Nov;3(6):659-67. doi: 10.1161/CIRCHEARTFAILURE.110.958785. Epub 2010 Sep 17.
•   Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP
  Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50.
•   Kitzman DW, Upadhya B, Reeves G
  Hospitalizations and Prognosis in Elderly Patients With Heart Failure and Preserved Ejection Fraction: Time to Treat the Whole Patient. JACC Heart Fail. 2015 Jun;3(6):442-444. doi: 10.1016/j.jchf.2015.01.009. Epub 2015 May 14.
•   Loffredo FS, Steinhauser ML, Jay SM, Gannon J, Pancoast JR, Yalamanchi P, Sinha M, Dall'Osso C, Khong D, Shadrach JL, Miller CM, Singer BS, Stewart A, Psychogios N, Gerszten RE, Hartigan AJ, Kim MJ, Serwold T, Wagers AJ, Lee RT
  Growth differentiation factor 11 is a circulating factor that reverses age-related cardiac hypertrophy. Cell. 2013 May 9;153(4):828-39. doi: 10.1016/j.cell.2013.04.015.
•   Middeldorp J, Lehallier B, Villeda SA, Miedema SS, Evans E, Czirr E, Zhang H, Luo J, Stan T, Mosher KI, Masliah E, Wyss-Coray T
  Preclinical Assessment of Young Blood Plasma for Alzheimer Disease. JAMA Neurol. 2016 Nov 1;73(11):1325-1333. doi: 10.1001/jamaneurol.2016.3185.
•   Misquita NA, Davis DC, Dobrovolny CL, Ryan AS, Dennis KE, Nicklas BJ
  Applicability of maximal oxygen consumption criteria in obese, postmenopausal women. J Womens Health Gend Based Med. 2001 Nov;10(9):879-85.
•   Nicklas BJ, Wang X, You T, Lyles MF, Demons J, Easter L, Berry MJ, Lenchik L, Carr JJ
  Effect of exercise intensity on abdominal fat loss during calorie restriction in overweight and obese postmenopausal women: a randomized, controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1043-52. doi: 10.3945/ajcn.2008.26938. Epub 2009 Feb 11.
•   Olivieri F, Capri M, Bonafè M, Morsiani C, Jung HJ, Spazzafumo L, Viña J, Suh Y
  Circulating miRNAs and miRNA shuttles as biomarkers: Perspective trajectories of healthy and unhealthy aging. Mech Ageing Dev. 2017 Jul;165(Pt B):162-170. doi: 10.1016/j.mad.2016.12.004. Epub 2016 Dec 13. Review.
•   Randolph C, Tierney MC, Mohr E, Chase TN
  The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9.
•   Reversing Epigenetic & Other Markers of Senescence by Transfusing Young Plasma To Older Human Subjects (RESET-YOUTH)
  Available from: https://clinicaltrials.gov/ct2/show/NCT03353597?term=Reset-YOuth&rank=1
•   Savarese, D
  Common Terminology Criteria for Adverse Events. 2019 [cited 2019 2019]; Available from: https://www.uptodate.com/contents/common-terminology-criteria-for-adverse-events?search=Common%20Terminology%20Criteria%20for%20Adverse%20Events.&source=search_result&selectedTitle=1~38&usage_type=default&display_rank=1
•   Shah SJ, Kitzman DW, Borlaug BA, van Heerebeek L, Zile MR, Kass DA, Paulus WJ
  Phenotype-Specific Treatment of Heart Failure With Preserved Ejection Fraction: A Multiorgan Roadmap. Circulation. 2016 Jul 5;134(1):73-90. doi: 10.1161/CIRCULATIONAHA.116.021884. Review.
•   Silvergleid, A
  J. Approach to the patient with a suspected acute transfusion reaction. 4/23/18]; Available from: https://www.uptodate.com/contents/approach-to-the-patient-with-a-suspected-acute-transfusion-reaction
•   Silvergleid, A
  J. Clinical Use of Plasma Components. [cited 2019]/ Available from: https://www.uptodate.com/contents/clinical-use-of-plasma-components
•   Sinha M, Jang YC, Oh J, Khong D, Wu EY, Manohar R, Miller C, Regalado SG, Loffredo FS, Pancoast JR, Hirshman MF, Lebowitz J, Shadrach JL, Cerletti M, Kim MJ, Serwold T, Goodyear LJ, Rosner B, Lee RT, Wagers AJ
  Restoring systemic GDF11 levels reverses age-related dysfunction in mouse skeletal muscle. Science. 2014 May 9;344(6184):649-52. doi: 10.1126/science.1251152. Epub 2014 May 5.
•   Stehle JR Jr, Leng X, Kitzman DW, Nicklas BJ, Kritchevsky SB, High KP
  Lipopolysaccharide-binding protein, a surrogate marker of microbial translocation, is associated with physical function in healthy older adults. J Gerontol A Biol Sci Med Sci. 2012 Nov;67(11):1212-8. doi: 10.1093/gerona/gls178. Epub 2012 Sep 7.
•   The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (PLASMA)
  Available from: https://clinicaltrials.gov/ct2/show/NCT02256306?term=PLASMA&rank=1
•   Triposkiadis F, Xanthopoulos A, Butler J
  Cardiovascular Aging and Heart Failure: JACC Review Topic of the Week. J Am Coll Cardiol. 2019 Aug 13;74(6):804-813. doi: 10.1016/j.jacc.2019.06.053. Review.
•   Upadhya B, Pisani B, Kitzman DW
  Evolution of a Geriatric Syndrome: Pathophysiology and Treatment of Heart Failure with Preserved Ejection Fraction. J Am Geriatr Soc. 2017 Nov;65(11):2431-2440. doi: 10.1111/jgs.15141. Review.

A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome

Details for clinical trial NCT04241159