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

University of Wisconsin, Madison43 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cardiovascular Disease Chronic Kidney Disease

Interventions

angiotensin converting enzyme inhibitorDRUG

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

lisinoprilDRUG

1 x 40 mg per day

Eligibility

Sex: ALLMin age: 60 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin-Madison Hospitals and Clinics

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Aortic Pulse Wave Velocity (PWV)

PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.

Time frame: up to 12 months

Secondary Outcomes

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)

Time frame: 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.

Time frame: up to 12 months

Data from ClinicalTrials.gov

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