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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Cardiovascular Disease

Treatments: Drug: angiotensin converting enzyme inhibitor; Drug: lisinopril

Study type: Interventional

Funder types: Other

Identifiers

NCT00874432

SMPH/MEDICINE/NEPHROLOGY (Other Identifier)

A534280 (Other Identifier)

H-2008-0221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 4 patient groups, including a placebo group

Chronic Kidney Disease-ACE-I

Active Comparator group

Description:

ace inhibitor

Treatment:

Drug: lisinopril

Chronic Kidney Disease

Placebo Comparator group

Treatment:

Drug: angiotensin converting enzyme inhibitor

Age matched control-ACE-I

Active Comparator group

Description:

ace-inhibitor

Treatment:

Drug: lisinopril

Age matched control

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: angiotensin converting enzyme inhibitor