Phase 2 N=43 Randomized Double-blind Treatment

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

Cardiovascular Disease · Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT00874432 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Aortic Pulse Wave Velocity (PWV) — 9.90; 9.96; 7.62; 8.57 m/s — p=0.685

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: angiotensin converting enzyme inhibitor (Drug); lisinopril (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Aortic Pulse Wave Velocity (PWV)	9.90; 9.96; 7.62; 8.57; 9.03; 8.38	0.685
SECONDARY Mean Vascular Stiffness As Measured by PWV	7.87; 6.28; 9.14; 8.17; 8.40; 8.28	0.685
SECONDARY Change in Blood Pressure From Baseline to 12 Months	—	—

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.

Eligibility Criteria

Inclusion Criteria

Age > 60 years
BP 120/80 or higher *(bps will be checked weekly first 4 weeks to ensure 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00874432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.