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

Sponsor:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00874432

Sponsor:

University of Wisconsin, Madison

Information provided by:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT00874432

Purpose

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.

Condition	Intervention
Cardiovascular Disease Chronic Kidney Disease	Drug: angiotensin converting enzyme inhibitor Drug: lisinopril

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effect of ACE-inhibitors on Aortic Stiffness in Elderly Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Lisinopril

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

There may be a statistical correlation between eGFR(estimated glomerular function) and PWV (pulse wave velocity) in patients with CKD, the addition of an ACE inhibitor will decrease PWV in all groups, but to a greater extent in patients wil CKD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Chronic Kidney Disease-ACE-I ace inhibitor	Drug: lisinopril 1 x 40 mg per day Other Name: ace inhibitor
Placebo Comparator: Chronic Kidney Disease	Drug: angiotensin converting enzyme inhibitor 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 Name: ACE-inhibitor
Active Comparator: Age matched control-ACE-I ace-inhibitor	Drug: lisinopril 1 x 40 mg per day Other Name: ace inhibitor
Placebo Comparator: Age matched control Placebo	Drug: angiotensin converting enzyme inhibitor 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 Name: ACE-inhibitor

Detailed Description:

Our 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, our work has important implications for improving the overall health of this population.

Eligibility

Ages Eligible for Study:	60 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 MI, recurrent stroke, or 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 ACE-I or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874432

Contacts

Contact: Bryan N Becker, MD	608-270-5690	bnb@medicine.wisc.edu
Contact: Lynn M Jacobson, BS	608-265-5489	lmj@medicine.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin-Madison Hospitals and Clinics	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Bryan N Becker, MD 608-270-5690 bnb@medicine.wisc.edu
Contact: Lynn M Jacobson, BS 608-265-5489 lmj@medicine.wisc.edu
Principal Investigator: Bryan N Becker, md
Sub-Investigator: Laura Maursetter, DO

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:	Bryan N Becker, MD	University of Wisconsin-Madison School of Medicine and Public Health
Study Director:	Laura Maursetter, DO	University of Wisconsin, Madison

Responsible Party:	Bryan N Becker, MD, UW-Madison School of Medicine and Public Health
ClinicalTrials.gov Identifier:	NCT00874432 History of Changes
Other Study ID Numbers:	2008-0221
Study First Received:	April 1, 2009
Last Updated:	March 25, 2010
Health Authority:	United States: Institutional Review Board