Assessment of Endothelial Function, Apolipoproteins and Adiponectin
NCT ID: NCT01300390
Last Updated: 2016-05-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
150 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-06-30
Study Completion Date
2015-10-31
Brief Summary
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The overall hypothesis is that endothelial function, apolipoprotein levels and adiponectin levels are accurate predictors of underlying cardiovascular disease in patients with end-stage liver disease, in whom standard tools for the diagnosis of and screening for cardiovascular disease are of limited utility.
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Detailed Description
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This study is looking at using a noninvasive test called a reactive hyperemia peripheral artery tonometry (RH-PAT) to check endothelial dysfunction. Endothelial dysfunction is thought to be an indication of future heart disease or metabolic disorders. Adiponectin is a hormone associated with heart disease. Apolipoprotein levels, are established risk factors for coronary artery disease in the general population. Our group would like to see if there is a link between endothelial function, adiponectin, apolipoprotein levels and posttransplant heart disease complications. The study would be taking these results to find new clinical procedures for patients that are at potentially higher risk of heart problems during and after their liver transplant procedure.
Conditions
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Cirrhosis
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Study Groups
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End-stage liver disease pre-transplant
Patients with end-stage liver disease (non-fulminant) awaiting liver transplant
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 21 years of age.
* Cirrhotic end-stage liver disease
* Pre-transplant
* Cirrhotic end-stage liver disease
* Pre-transplant
Exclusion Criteria
* Dialysis shunt
* non-cirrhotic liver disease
* fulminant hepatic failure
* non-cirrhotic liver disease
* fulminant hepatic failure
Minimum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Mayo Clinic
OTHER
Sponsor Role
lead
Responsible Party
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Kymberly D. Watt
M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kymberly Watt, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Site Status
Countries
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United States
References
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Carey WD, Dumot JA, Pimentel RR, Barnes DS, Hobbs RE, Henderson JM, Vogt DP, Mayes JT, Westveer MK, Easley KA. The prevalence of coronary artery disease in liver transplant candidates over age 50. Transplantation. 1995 Mar 27;59(6):859-64.
Reference Type
BACKGROUND
Tiukinhoy-Laing SD, Rossi JS, Bayram M, De Luca L, Gafoor S, Blei A, Flamm S, Davidson CJ, Gheorghiade M. Cardiac hemodynamic and coronary angiographic characteristics of patients being evaluated for liver transplantation. Am J Cardiol. 2006 Jul 15;98(2):178-81. doi: 10.1016/j.amjcard.2006.01.089. Epub 2006 May 12.
Reference Type
BACKGROUND
Diedrich DA, Findlay JY, Harrison BA, Rosen CB. Influence of coronary artery disease on outcomes after liver transplantation. Transplant Proc. 2008 Dec;40(10):3554-7. doi: 10.1016/j.transproceed.2008.08.129.
Reference Type
BACKGROUND
John PR, Thuluvath PJ. Outcome of liver transplantation in patients with diabetes mellitus: a case-control study. Hepatology. 2001 Nov;34(5):889-95. doi: 10.1053/jhep.2001.29134.
Reference Type
BACKGROUND
Bianchi G, Marchesini G, Marzocchi R, Pinna AD, Zoli M. Metabolic syndrome in liver transplantation: relation to etiology and immunosuppression. Liver Transpl. 2008 Nov;14(11):1648-54. doi: 10.1002/lt.21588.
Reference Type
BACKGROUND
Reuben A. Long-term management of the liver transplant patient: diabetes, hyperlipidemia, and obesity. Liver Transpl. 2001 Nov;7(11 Suppl 1):S13-21. doi: 10.1053/jlts.2001.29167.
Reference Type
BACKGROUND
Leonard J, Heimbach JK, Malinchoc M, Watt K, Charlton M. The impact of obesity on long-term outcomes in liver transplant recipients-results of the NIDDK liver transplant database. Am J Transplant. 2008 Mar;8(3):667-72. doi: 10.1111/j.1600-6143.2007.02100.x.
Reference Type
BACKGROUND
Moller S, Henriksen JH. Cirrhotic cardiomyopathy: a pathophysiological review of circulatory dysfunction in liver disease. Heart. 2002 Jan;87(1):9-15. doi: 10.1136/heart.87.1.9.
Reference Type
BACKGROUND
Therapondos G, Flapan AD, Plevris JN, Hayes PC. Cardiac morbidity and mortality related to orthotopic liver transplantation. Liver Transpl. 2004 Dec;10(12):1441-53. doi: 10.1002/lt.20298.
Reference Type
BACKGROUND
Keeffe BG, Valantine H, Keeffe EB. Detection and treatment of coronary artery disease in liver transplant candidates. Liver Transpl. 2001 Sep;7(9):755-61. doi: 10.1053/jlts.2001.26063.
Reference Type
BACKGROUND
Findlay JY, Keegan MT, Pellikka PP, Rosen CB, Plevak DJ. Preoperative dobutamine stress echocardiography, intraoperative events, and intraoperative myocardial injury in liver transplantation. Transplant Proc. 2005 Jun;37(5):2209-13. doi: 10.1016/j.transproceed.2005.03.023.
Reference Type
BACKGROUND
Umphrey LG, Hurst RT, Eleid MF, Lee KS, Reuss CS, Hentz JG, Vargas HE, Appleton CP. Preoperative dobutamine stress echocardiographic findings and subsequent short-term adverse cardiac events after orthotopic liver transplantation. Liver Transpl. 2008 Jun;14(6):886-92. doi: 10.1002/lt.21495.
Reference Type
BACKGROUND
Takase B, Uehata A, Akima T, Nagai T, Nishioka T, Hamabe A, Satomura K, Ohsuzu F, Kurita A. Endothelium-dependent flow-mediated vasodilation in coronary and brachial arteries in suspected coronary artery disease. Am J Cardiol. 1998 Dec 15;82(12):1535-9, A7-8. doi: 10.1016/s0002-9149(98)00702-4.
Reference Type
BACKGROUND
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
Reference Type
BACKGROUND
Yeboah J, Crouse JR, Hsu FC, Burke GL, Herrington DM. Brachial flow-mediated dilation predicts incident cardiovascular events in older adults: the Cardiovascular Health Study. Circulation. 2007 May 8;115(18):2390-7. doi: 10.1161/CIRCULATIONAHA.106.678276. Epub 2007 Apr 23.
Reference Type
BACKGROUND
Yeboah J, Folsom AR, Burke GL, Johnson C, Polak JF, Post W, Lima JA, Crouse JR, Herrington DM. Predictive value of brachial flow-mediated dilation for incident cardiovascular events in a population-based study: the multi-ethnic study of atherosclerosis. Circulation. 2009 Aug 11;120(6):502-9. doi: 10.1161/CIRCULATIONAHA.109.864801. Epub 2009 Jul 27.
Reference Type
BACKGROUND
Gokce N, Keaney JF Jr, Hunter LM, Watkins MT, Menzoian JO, Vita JA. Risk stratification for postoperative cardiovascular events via noninvasive assessment of endothelial function: a prospective study. Circulation. 2002 Apr 2;105(13):1567-72. doi: 10.1161/01.cir.0000012543.55874.47.
Reference Type
BACKGROUND
Gastaldelli A, Kozakova M, Hojlund K, Flyvbjerg A, Favuzzi A, Mitrakou A, Balkau B; RISC Investigators. Fatty liver is associated with insulin resistance, risk of coronary heart disease, and early atherosclerosis in a large European population. Hepatology. 2009 May;49(5):1537-44. doi: 10.1002/hep.22845.
Reference Type
BACKGROUND
Villanova N, Moscatiello S, Ramilli S, Bugianesi E, Magalotti D, Vanni E, Zoli M, Marchesini G. Endothelial dysfunction and cardiovascular risk profile in nonalcoholic fatty liver disease. Hepatology. 2005 Aug;42(2):473-80. doi: 10.1002/hep.20781.
Reference Type
BACKGROUND
Berg AH, Scherer PE. Adipose tissue, inflammation, and cardiovascular disease. Circ Res. 2005 May 13;96(9):939-49. doi: 10.1161/01.RES.0000163635.62927.34.
Reference Type
BACKGROUND
Rajsheker S, Manka D, Blomkalns AL, Chatterjee TK, Stoll LL, Weintraub NL. Crosstalk between perivascular adipose tissue and blood vessels. Curr Opin Pharmacol. 2010 Apr;10(2):191-6. doi: 10.1016/j.coph.2009.11.005. Epub 2010 Jan 7.
Reference Type
BACKGROUND
Hopkins TA, Ouchi N, Shibata R, Walsh K. Adiponectin actions in the cardiovascular system. Cardiovasc Res. 2007 Apr 1;74(1):11-8. doi: 10.1016/j.cardiores.2006.10.009. Epub 2006 Oct 20.
Reference Type
BACKGROUND
Zhu W, Cheng KK, Vanhoutte PM, Lam KS, Xu A. Vascular effects of adiponectin: molecular mechanisms and potential therapeutic intervention. Clin Sci (Lond). 2008 Mar;114(5):361-74. doi: 10.1042/CS20070347.
Reference Type
BACKGROUND
Kaser S, Moschen A, Cayon A, Kaser A, Crespo J, Pons-Romero F, Ebenbichler CF, Patsch JR, Tilg H. Adiponectin and its receptors in non-alcoholic steatohepatitis. Gut. 2005 Jan;54(1):117-21. doi: 10.1136/gut.2003.037010.
Reference Type
BACKGROUND
Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. doi: 10.1161/01.atv.0000051384.43104.fc.
Reference Type
BACKGROUND
Other Identifiers
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10-008776
Identifier Type: -
Identifier Source: org_study_id
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