Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2|
- To compare the effect of ACE inhibition or AT1 receptor blockade versus placebo on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis [ Time Frame: end of each study ] [ Designated as safety issue: Yes ]
- To compare the effect of ACE inhibition versus AT1 receptor blockade on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis [ Time Frame: end of each study ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
After a washout period, subject will undertake 3 study periods with one of the three treatments: Ramipril initiated at 2.5 mg/d for 2 days followed by 5 mg for a total of nine days
Other Name: Altace
Active Comparator: 2
After a three week washout period, each subject will be randomized to receive one of the three treatments, placebo, ramipril or valsartan
After a three week washout period, each subject will undertake 3 study periods with one of three treatment: Valsartan initiated at 80 mg/d for 2 days followed by 160 mg/d for a total of 9 days
Other Name: Diovan
Placebo Comparator: 3
After a three week washout period, each subject will undertake 3 study periods with one of the three treatments, placebo, ramipril or valsartan
After a three week washout period, subject will undertake 3 study periods with one of three treatments: Placebo (inactive pill) for nine days.
Other Name: Placebo
- 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
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37323|
|Principal Investigator:||Nancy J Brown, MD||Vanderbilt University|