Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Dialysis; Hemodialysis
Intervention: ramipril (Drug); valsartan (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Nancy J Brown, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Delia M Woods, BSN, Phone: 615-322-3371, Email: delia.woods@vanderbilt.edu
Summary
Little is known about how some drugs affect inflammation or clotting factors in people
receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they
do in people not undergoing hemodialysis or whether they could increase the risk of heart
problems. The purpose of the study is to measure certain chemicals in the blood and see how
those chemicals may change during hemodialysis when certain drugs are given.
Clinical Details
Official title: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2
Study design: Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacokinetics Study
Primary outcome: To compare the effect of ACE inhibition or AT1 receptor blockade versus placebo on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis
Secondary outcome: To compare the effect of ACE inhibition versus AT1 receptor blockade on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis
Detailed description:
- Cardiovascular disease in the leading cause of death in patients with chronic kidney
disease undergoing hemodialysis.
- Traditional risk factors do not adequately predict cardiovascular morbidity and
mortality in patients with chronic kidney disease.
- Increased oxidative stress, inflammation and impaired fibrinolysis contribute to
cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.
- Activation of the RAAS may contribute to oxidative stress and inflammation in
individuals with chronic kidney disease
- Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis
but may also contribute to inflammation in chronic kidney disease
- Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease
cardiovascular mortality, delay progression to cardiovascular disease and decrease the
incidence of diabetes in the general population little is known about the impact of
these agents on cardiovascular morbidity and mortality in patients with end- stage
renal disease (ESRD) undergoing hemodialysis
- ACE inhibitors and ARBS differ in their mechanisms of action and their effects on
inflammatory biomarkers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 18 years or older
- On thrice-weekly chronic hemodialysis for at least 6 months
- Clinically stable, adequately dialyzed (single-pool Kt/V> 1. 2) thrice weekly, with
polysulphone membrane for at least 3 consecutive months prior to study
Exclusion Criteria:
- Body mass index > 35 mg/kg
- History of functional transplant less than 6 months prior to study
- Use of anti-inflammatory medications other than aspirin < 325 mg/d
- History of active connective tissue disease
- History of acute infectious disease within one month prior to study
- AIDS (HIV seropositivity is not an exclusion criteria)
- History of myocardial infarction or cerebrovascular event within 3 months
- Advanced liver disease
- Gastrointestinal dysfunction requiring parental nutrition
- Active malignancy excluding basal cell carcinoma of the skin
- History of ACE inhibitor-associated cough or angioedema
- Ejection fraction less than 40%
- Inability to discontinue ACE inhibitor or ARB
- Predialysis potassium repeatedly higher than 5. 5 mmol/L (confirmed on a repeated
blood draw)
- Anticipated live donor kidney transplant
- Use of vitamin E >60 IU/d or vitamin C >500 mg/d
- Pregnancy, breast-feeding or child-bearing potential
- History of poor adherence to hemodialysis or medical regimen
- Inability to provide consent
Locations and Contacts
Delia M Woods, BSN, Phone: 615-322-3371, Email: delia.woods@vanderbilt.edu
Vanderbilt University Medical Center, Nashville, Tennessee 37323, United States; Recruiting
Delia M Woods, BSN, Phone: 615-322-3371, Email: delia.woods@vanderbilt.edu
Nancy J Brown, MD, Principal Investigator
Josh Billings, MD, Sub-Investigator
Additional Information
Starting date: August 2008
Ending date: August 2010
Last updated: August 13, 2009
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