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

Primary Purpose

Cardiovascular Disease, Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
angiotensin converting enzyme inhibitor
lisinopril
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring cardiovascular disease, angiotensin converting enzyme inhibitors, chronic kidney disease, cardiovascular disease in elderly patients with CKD

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Wisconsin-Madison Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Chronic Kidney Disease-ACE-I

Chronic Kidney Disease

Age matched control-ACE-I

Age matched control

Arm Description

ace inhibitor

ace-inhibitor

Placebo

Outcomes

Primary Outcome Measures

Aortic Pulse Wave Velocity (PWV)
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.

Secondary Outcome Measures

Mean Vascular Stiffness As Measured by PWV
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
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.

Full Information

First Posted
April 1, 2009
Last Updated
October 8, 2020
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00874432
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Chronic Kidney Disease
Keywords
cardiovascular disease, angiotensin converting enzyme inhibitors, chronic kidney disease, cardiovascular disease in elderly patients with CKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Kidney Disease-ACE-I
Arm Type
Active Comparator
Arm Description
ace inhibitor
Arm Title
Chronic Kidney Disease
Arm Type
Placebo Comparator
Arm Title
Age matched control-ACE-I
Arm Type
Active Comparator
Arm Description
ace-inhibitor
Arm Title
Age matched control
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
angiotensin converting enzyme inhibitor
Other Intervention Name(s)
ACE-inhibitor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
lisinopril
Other Intervention Name(s)
ace inhibitor
Intervention Description
1 x 40 mg per day
Primary Outcome Measure Information:
Title
Aortic Pulse Wave Velocity (PWV)
Description
PWV will be measured in patients over age 60 with stage 3 CKD and age matched controls without CKD.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Mean Vascular Stiffness As Measured by PWV
Description
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)
Time Frame
baseline and 12 months
Title
Change in Blood Pressure From Baseline to 12 Months
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arjang Djamali, MD
Organizational Affiliation
University of Wisconsin-Madison School of Medicine and Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Maursetter, DO
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Director
Facility Information:
Facility Name
University of Wisconsin-Madison Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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