Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00874432
First received: April 1, 2009
Last updated: March 25, 2010
Last verified: March 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

Publications:
. Kundhal K, Lok C.E. Clinical epidemiology of cardiovascular disease in chronic kidney disease. Nephron Clin Practice. 101:c47-c52, 2005.
Djamali A, Sadowski E, Muehrer R, et al. Losartan Improves Renal Medullary Oxygena tion and Oxidative Stress in Patients with Chronic Allograft Nephropathy. J.Am.Soc.Nephrol. 15(Abstract Issue):SA-PO1026, 2004

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

Keywords provided by University of Wisconsin, Madison:
cardiovascular disease
angiotensin converting enzyme inhibitors
chronic kidney disease
cardiovascular disease in elderly patients with CKD

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014