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Completed

NCT Number: NCT00874432

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

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin-Madison Hospitals and Clinics

Madison, Wisconsin, 53792, United States

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin Converting Enzyme Inhibitor

Drug

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

Other names: ACE-inhibitor

Lisinopril

Drug

1 x 40 mg per day

Other names: ace inhibitor

Primary outcomes

  1. Aortic Pulse Wave Velocity (PWV)

    Time frame: up to 12 months

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

Secondary outcomes

  1. Mean Vascular Stiffness As Measured by PWV

    Time frame: 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)

  2. Change in Blood Pressure From Baseline to 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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