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

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ClinicalTrials.gov Identifier: NCT00874432
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Chronic Kidney Disease Drug: angiotensin converting enzyme inhibitor Drug: lisinopril Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Study Start Date : March 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Lisinopril

Arm Intervention/treatment
Active Comparator: Chronic Kidney Disease-ACE-I
ace inhibitor
Drug: lisinopril
1 x 40 mg per day
Other Name: ace inhibitor

Placebo Comparator: Chronic Kidney Disease Drug: angiotensin converting enzyme inhibitor
Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
Other Name: ACE-inhibitor

Active Comparator: Age matched control-ACE-I
ace-inhibitor
Drug: lisinopril
1 x 40 mg per day
Other Name: ace inhibitor

Placebo Comparator: Age matched control
Placebo
Drug: angiotensin converting enzyme inhibitor
Active comparator in chronic kidney disease and age matched control will take 1x40mg per day Placebo comparator in chronic kidney disease and age matched control will take 1 placebo pill per day
Other Name: ACE-inhibitor




Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]


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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874432


Locations
United States, Wisconsin
University of Wisconsin-Madison Hospitals and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Bryan N Becker, MD University of Wisconsin-Madison School of Medicine and Public Health
Study Director: Laura Maursetter, DO University of Wisconsin, Madison

Publications:
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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00874432     History of Changes
Other Study ID Numbers: H-2008-0221
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
cardiovascular disease
angiotensin converting enzyme inhibitors
chronic kidney disease
cardiovascular disease in elderly patients with CKD

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs