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Effect of ACE-Inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disease; Chronic Kidney Disease

Intervention: angiotensin converting enzyme inhibitor (Drug); lisinopril (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Lisa M Nanovic, DO, Principal Investigator, Affiliation: University of Wisconsin-Madison School of Medicine and Public Health

Overall contact:
Lisa M Nanovic, DO, Phone: 608-270-5656, Email: ln3@medicine.wisc.edu

Summary

The goal of this proposal is to investigate the potential for ACE-inhibitors (ACE-I)(drugs primarily used to treat hypertension or congestive heart failure) to prevent or delay cardiovascular disease (CVD) in older adults with chronic kidney disease (CKD) by examining their impact on aortic stiffness in people with stage 3 CKD in a randomized, controlled study.

Clinical Details

Official title: Effect of ACE-Inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study

Primary outcome: There may be a statistical correlation between eGFR(estimated glomerular function) and PWV (pulse wave velocity) in patients with CKD, the addition of an ACE inhibitor will decrease PWV in all groups, but to a greater extent in patients wil CKD.

Detailed description: Our study will be the first to examine whether aortic stiffness is increased in elderly patients with CKD compared to their age-matched healthy controls and further examine whether ACE-I may delay the progression of aortic stiffness in elderly CKD patients. If ACE-I therapy appears beneficial in preventing or delaying arterial stiffening in elderly patients with CKD, our work has important implications for improving the overall health of this population.

Eligibility

Minimum age: 60 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > 60 years

- BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure < 130/80

- IF bp remains > 130/80 we will administer other bp meds per JNC VII guidelines)

- CKD stage 3 (GFR 30 - 59 ml/min) for CKD group; no CKD for control group

Exclusion Criteria:

- Known significant CVD (history of MI, recurrent stroke, or NYHA class III or

greater).

- Serum potassium > 5. 2 meq/L

- Known allergy or hypersensitivity to ACE inhibitor or ARB

- Female of childbearing age not practicing contraception

- Current treatment with an ACE-I or ARB (Note: can participate if on ACE-I after 6

week washout period)

- History of ACE-I induced angioedema

- History of angioedema, hereditary or idiopathic

- Persons lacking consent capacity

- 500 mg/dL proteinuria on 2 consecutive spot urine protein/creat ratios

Locations and Contacts

Lisa M Nanovic, DO, Phone: 608-270-5656, Email: ln3@medicine.wisc.edu

University of Wisconsin-Madison Hospitals and Clinics, Madison, Wisconsin 53792, United States; Recruiting
Lisa M Nanovic, DO, Phone: 608-270-5656, Email: ln3@medicine.wisc.edu
Lynn M Jacobson, BS, Phone: 608-265-5489, Email: lmj@medicine.wisc.edu
Lisa M Nanovic, DO, Principal Investigator
Additional Information

Related publications:

Ryan TP, Sloand JA, Winters PC, Corsetti JP, Fisher SG. Chronic kidney disease prevalence and rate of diagnosis. Am J Med. 2007 Nov;120(11):981-6.

Foley RN, Parfrey PS. Cardiovascular disease and mortality in ESRD. J Nephrol. 1998 Sep-Oct;11(5):239-45. Review.

Blacher J, Guerin AP, Pannier B, Marchais SJ, London GM. Arterial calcifications, arterial stiffness, and cardiovascular risk in end-stage renal disease. Hypertension. 2001 Oct;38(4):938-42.

Covic A, Haydar AA, Bhamra-Ariza P, Gusbeth-Tatomir P, Goldsmith DJ. Aortic pulse wave velocity and arterial wave reflections predict the extent and severity of coronary artery disease in chronic kidney disease patients. J Nephrol. 2005 Jul-Aug;18(4):388-96.

London GM, Marchais SJ, Guerin AP. Arterial stiffness and function in end-stage renal disease. Adv Chronic Kidney Dis. 2004 Apr;11(2):202-9. Review.

Wang MC, Tsai WC, Chen JY, Huang JJ. Stepwise increase in arterial stiffness corresponding with the stages of chronic kidney disease. Am J Kidney Dis. 2005 Mar;45(3):494-501.

. Kundhal K, Lok C.E. Clinical epidemiology of cardiovascular disease in chronic kidney disease. Nephron Clin Practice. 101:c47-c52, 2005.

Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70.

London GM, Guerin AP, Marchais SJ, Pannier B, Safar ME, Day M, Metivier F. Cardiac and arterial interactions in end-stage renal disease. Kidney Int. 1996 Aug;50(2):600-8.

Shinohara K, Shoji T, Tsujimoto Y, Kimoto E, Tahara H, Koyama H, Emoto M, Ishimura E, Miki T, Tabata T, Nishizawa Y. Arterial stiffness in predialysis patients with uremia. Kidney Int. 2004 Mar;65(3):936-43.

Safar ME, London GM, Plante GE. Arterial stiffness and kidney function. Hypertension. 2004 Feb;43(2):163-8. Epub 2004 Jan 19. Review.

Willum-Hansen T, Staessen JA, Torp-Pedersen C, Rasmussen S, Thijs L, Ibsen H, Jeppesen J. Prognostic value of aortic pulse wave velocity as index of arterial stiffness in the general population. Circulation. 2006 Feb 7;113(5):664-70.

Dao HH, Essalihi R, Bouvet C, Moreau P. Evolution and modulation of age-related medial elastocalcinosis: impact on large artery stiffness and isolated systolic hypertension. Cardiovasc Res. 2005 May 1;66(2):307-17. Review.

Ferrari AU, Radaelli A, Centola M. Invited review: aging and the cardiovascular system. J Appl Physiol. 2003 Dec;95(6):2591-7. Review.

Mitchell GF, Parise H, Benjamin EJ, Larson MG, Keyes MJ, Vita JA, Vasan RS, Levy D. Changes in arterial stiffness and wave reflection with advancing age in healthy men and women: the Framingham Heart Study. Hypertension. 2004 Jun;43(6):1239-45. Epub 2004 May 3.

Sawabe M, Takahashi R, Matsushita S, Ozawa T, Arai T, Hamamatsu A, Nakahara K, Chida K, Yamanouchi H, Murayama S, Tanaka N. Aortic pulse wave velocity and the degree of atherosclerosis in the elderly: a pathological study based on 304 autopsy cases. Atherosclerosis. 2005 Apr;179(2):345-51. Epub 2004 Dec 13.

London GM, Marchais SJ, Guerin AP, Pannier B. Arterial stiffness: pathophysiology and clinical impact. Clin Exp Hypertens. 2004 Oct-Nov;26(7-8):689-99. Review.

London GM, Marchais SJ, Guérin AP, Métivier F. Arteriosclerosis, vascular calcifications and cardiovascular disease in uremia. Curr Opin Nephrol Hypertens. 2005 Nov;14(6):525-31. Review.

Touyz RM. The role of angiotensin II in regulating vascular structural and functional changes in hypertension. Curr Hypertens Rep. 2003 Apr;5(2):155-64. Review.

Unger T. Pharmacological properties of angiotensin II antagonists: examining all the therapeutic implications. J Renin Angiotensin Aldosterone Syst. 2001 Sep;2 Suppl 2:S4-7. Review.

Matsuda H, Hayashi K, Saruta T. Distinct time courses of renal protective action of angiotensin receptor antagonists and ACE inhibitors in chronic renal disease. J Hum Hypertens. 2003 Apr;17(4):271-6.

Chrysant SG. Vascular remodeling: the role of angiotensin-converting enzyme inhibitors. Am Heart J. 1998 Feb;135(2 Pt 2):S21-30. Review.

Bertrand ME. Provision of cardiovascular protection by ACE inhibitors: a review of recent trials. Curr Med Res Opin. 2004 Oct;20(10):1559-69. Review.

Fields LE, Burt VL, Cutler JA, Hughes J, Roccella EJ, Sorlie P. The Burden of Adult Hypertension in the United States 1999 to 2000. A Rising Tide. Hypertension. 2004 Aug 23 [Epub ahead of print]

Vasan RS, Beiser A, Seshadri S, Larson MG, Kannel WB, D'Agostino RB, Levy D. Residual lifetime risk for developing hypertension in middle-aged women and men: The Framingham Heart Study. JAMA. 2002 Feb 27;287(8):1003-10.

Franklin SS, Gustin W 4th, Wong ND, Larson MG, Weber MA, Kannel WB, Levy D. Hemodynamic patterns of age-related changes in blood pressure. The Framingham Heart Study. Circulation. 1997 Jul 1;96(1):308-15.

Lloyd-Jones DM, Evans JC, Levy D. Hypertension in adults across the age spectrum: current outcomes and control in the community. JAMA. 2005 Jul 27;294(4):466-72.

Hansson L, Zanchetti A, Carruthers SG, Dahlöf B, Elmfeldt D, Julius S, Ménard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998 Jun 13;351(9118):1755-62.

Darne B, Girerd X, Safar M, Cambien F, Guize L. Pulsatile versus steady component of blood pressure: a cross-sectional analysis and a prospective analysis on cardiovascular mortality. Hypertension. 1989 Apr;13(4):392-400.

Mitchell GF, Lacourcière Y, Ouellet JP, Izzo JL Jr, Neutel J, Kerwin LJ, Block AJ, Pfeffer MA. Determinants of elevated pulse pressure in middle-aged and older subjects with uncomplicated systolic hypertension: the role of proximal aortic diameter and the aortic pressure-flow relationship. Circulation. 2003 Sep 30;108(13):1592-8. Epub 2003 Sep 15.

Hallan S, Asberg A, Lindberg M, Johnsen H. Validation of the Modification of Diet in Renal Disease formula for estimating GFR with special emphasis on calibration of the serum creatinine assay. Am J Kidney Dis. 2004 Jul;44(1):84-93.

Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100.

McEniery CM, Yasmin, Hall IR, Qasem A, Wilkinson IB, Cockcroft JR; ACCT Investigators. Normal vascular aging: differential effects on wave reflection and aortic pulse wave velocity: the Anglo-Cardiff Collaborative Trial (ACCT). J Am Coll Cardiol. 2005 Nov 1;46(9):1753-60. Epub 2005 Oct 10.

Mitchell GF, Izzo JL Jr, Lacourcière Y, Ouellet JP, Neutel J, Qian C, Kerwin LJ, Block AJ, Pfeffer MA. Omapatrilat reduces pulse pressure and proximal aortic stiffness in patients with systolic hypertension: results of the conduit hemodynamics of omapatrilat international research study. Circulation. 2002 Jun 25;105(25):2955-61.

Bakris GL, Weir MR. Angiotensin-converting enzyme inhibitor-associated elevations in serum creatinine: is this a cause for concern? Arch Intern Med. 2000 Mar 13;160(5):685-93.

Djamali A, Sadowski E, Muehrer R, et al. Losartan Improves Renal Medullary Oxygena tion and Oxidative Stress in Patients with Chronic Allograft Nephropathy. J.Am.Soc.Nephrol. 15(Abstract Issue):SA-PO1026, 2004

Starting date: March 2009
Ending date: March 2012
Last updated: April 1, 2009

Page last updated: October 19, 2009

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