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

Study Overview
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Brief Summary
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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.

Detailed Description
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This 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, this work has important implications for improving the overall health of this population.

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

Conditions
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Cardiovascular Disease, Chronic Kidney Disease

Intervention / Treatment
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* Drug: angiotensin converting enzyme inhibitor
* Drug: lisinopril


Participation Criteria
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Eligibility Criteria
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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 Myocardial infarction (MI), recurrent stroke, or New York Heart Association (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 Angiotensin Converting Enzyme Inhibitors (ACE-I) or Angiotensin-Receptor Blockers (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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronic Kidney Disease-ACE-I<br>ace inhibitor | Drug: lisinopril<br>* 1 x 40 mg per day<br>* Other names: ace inhibitor;|
| Placebo Comparator: Chronic Kidney Disease<br> | Drug: angiotensin converting enzyme inhibitor<br>* 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<br>* Other names: ACE-inhibitor;|
| Active Comparator: Age matched control-ACE-I<br>ace-inhibitor | Drug: lisinopril<br>* 1 x 40 mg per day<br>* Other names: ace inhibitor;|
| Placebo Comparator: Age matched control<br>Placebo | Drug: angiotensin converting enzyme inhibitor<br>* 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<br>* Other names: ACE-inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Pulse Wave Velocity (PWV) | PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Vascular Stiffness As Measured by PWV | Comparison between Participants with Stage 3 Chronic Kidney Disease (CKD) and age matched Controls without CKD. The numbers reported are the mean of all the participants in the group at two points in time - the baseline and at 12 months for CFPWV, CBPWV, and CRPWV. Carotid-Femoral Pulse Wave Velocity (CFPWV) Carotid-Brachial Pulse Wave Velocity (CBPWV) Carotid-Radial Pulse Wave Velocity (CRPWV) | baseline and 12 months | 
| Change in Blood Pressure From Baseline to 12 Months | Change in Blood Pressure will be used to measure the effect of ACE-inhibitors on the clinical markers of Cardiovascular Disease in participants with stage 3 CKD. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, angiotensin converting enzyme inhibitors, chronic kidney disease, cardiovascular disease in elderly patients with CKD