Clinical trial NCT00874432: Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Official title: Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Chronic Kidney Disease
Keywords: cardiovascular disease
angiotensin converting enzyme inhibitors
chronic kidney disease
cardiovascular disease in elderly patients with CKD
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aortic Pulse Wave Velocity (PWV)
timeFrame: up to 12 months
Secondary outcomes:
measure: Mean Vascular Stiffness As Measured by PWV
timeFrame: baseline and 12 months
measure: Change in Blood Pressure From Baseline to 12 Months
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison Hospitals and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin-Madison School of Medicine and Public Health
name: Arjang Djamali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Laura Maursetter, DO
role: STUDY_DIRECTOR
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