Cardiovascular Disease | Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Cardiovascular Disease research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Kidney Disease
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:angiotensin converting enzyme inhibitorActive 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
Drug:lisinopril1 x 40 mg per day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Chronic Kidney Disease-ACE-Iace inhibitor
Chronic Kidney Disease
Age matched control-ACE-Iace-inhibitor
Age matched controlPlacebo
Start Date: March 2009
Completed Date: December 2011
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.
Study sponsors, principal investigator, and references
Principal Investigator: Bryan N Becker, MD
Lead Sponsor: University of Wisconsin, Madison
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.