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

Phase 2

Completed

Interventions: Drug: angiotensin converting enzyme inhibitor
Drug: lisinopril

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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Disease	angiotensin converting enzyme inhibitor	-
Chronic Kidney Disease-ACE-I	lisinopril	ace inhibitor
Age matched control	angiotensin converting enzyme inhibitor	Placebo
Age matched control-ACE-I	lisinopril	ace-inhibitor

Primary Outcome Measures

Name	Time	Method
Aortic Pulse Wave Velocity (PWV)	up to 12 months	PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.

Secondary Outcome Measures

Name	Time	Method
Mean Vascular Stiffness As Measured by PWV	baseline and 12 months	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)
Change in Blood Pressure From Baseline to 12 Months	up 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.