Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069810
Status:
WITHDRAWN
Last Update Posted:
2017-04-06
First Post:
2003-10-01
Brief Title:
Role of Chronic Kidney Disease in Cardiovascular Disease
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Oxidative Stress in Chronic Kidney Disease
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is not a clinical trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how the progressive loss of kidney function influences cardiovascular disease
Detailed Description:
BACKGROUND
Currently both the incidence and prevalence of chronic kidney disease leading to end-stage renal disease ESRD continue to increase at an alarming rate in the United States According to the United States Renal Data System in 2000 there were 370000 prevalent ESRD patients which was expected to grow to 610000 by the year 2010 Furthermore the adjusted death rate for all incident ESRD patients was 198 per 100 patient years at risk with cardiovascular disease accounting for more than 50 percent of mortality in this patient population Recent analyses demonstrate that there are at least 109 million people in the United States with chronic kidney disease and that for this population there are substantially increased cardiovascular risks prompting the Surgeon General to include chronic kidney disease as a focus area for improving the nations health in Healthy People 2010 The metabolic derangements accompanying progressive loss of kidney function lead to unique patterns of oxidative injury specific to the uremic state For patients with chronic kidney disease non-traditional risk factors for cardiovascular disease such as increased oxidative stress and inflammation may be especially important
DESIGN NARRATIVE
The broad goals of this study are to develop enhanced understanding of how the progressive loss of kidney function leads to increased oxidative stress inflammation and accelerated development of cardiovascular disease The long-term objective of this proposal is to develop the data critical for a subsequent large scale multicenter randomized controlled trial designed to alleviate oxidative stress reduce inflammation and reduce cardiovascular morbidity in patients with chronic kidney disease The aims of this study are to determine in a prospective study the extent to which oxidative stress is a risk factor for cardiovascular events in patients with chronic kidney disease and to characterize the inter-relationships between oxidative stress and inflammation A further aim is to determine in the longitudinal study is how progressive loss of kidney function influences oxidative stress propensity to inflammation and cardiovascular disease An additional aim is to determine the effects of antioxidant therapy on biomarkers of oxidative stress markers of inflammation and endothelium-dependent vascular function in patients with chronic kidney disease This study incorporates a series of observational and interventional studies measuring the extent of cardiovascular disease with extensive ex vivo measures of biomarkers of oxidative stress and inflammation in patients with chronic kidney disease Coordination between the clinical data and the ex vivo studies will be emphasized to achieve maximal understanding of the pathophysiology of uremic cardiovascular disease
Currently both the incidence and prevalence of chronic kidney disease leading to end-stage renal disease ESRD continue to increase at an alarming rate in the United States According to the United States Renal Data System in 2000 there were 370000 prevalent ESRD patients which was expected to grow to 610000 by the year 2010 Furthermore the adjusted death rate for all incident ESRD patients was 198 per 100 patient years at risk with cardiovascular disease accounting for more than 50 percent of mortality in this patient population Recent analyses demonstrate that there are at least 109 million people in the United States with chronic kidney disease and that for this population there are substantially increased cardiovascular risks prompting the Surgeon General to include chronic kidney disease as a focus area for improving the nations health in Healthy People 2010 The metabolic derangements accompanying progressive loss of kidney function lead to unique patterns of oxidative injury specific to the uremic state For patients with chronic kidney disease non-traditional risk factors for cardiovascular disease such as increased oxidative stress and inflammation may be especially important
DESIGN NARRATIVE
The broad goals of this study are to develop enhanced understanding of how the progressive loss of kidney function leads to increased oxidative stress inflammation and accelerated development of cardiovascular disease The long-term objective of this proposal is to develop the data critical for a subsequent large scale multicenter randomized controlled trial designed to alleviate oxidative stress reduce inflammation and reduce cardiovascular morbidity in patients with chronic kidney disease The aims of this study are to determine in a prospective study the extent to which oxidative stress is a risk factor for cardiovascular events in patients with chronic kidney disease and to characterize the inter-relationships between oxidative stress and inflammation A further aim is to determine in the longitudinal study is how progressive loss of kidney function influences oxidative stress propensity to inflammation and cardiovascular disease An additional aim is to determine the effects of antioxidant therapy on biomarkers of oxidative stress markers of inflammation and endothelium-dependent vascular function in patients with chronic kidney disease This study incorporates a series of observational and interventional studies measuring the extent of cardiovascular disease with extensive ex vivo measures of biomarkers of oxidative stress and inflammation in patients with chronic kidney disease Coordination between the clinical data and the ex vivo studies will be emphasized to achieve maximal understanding of the pathophysiology of uremic cardiovascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070938 | NIH | None | httpsreporternihgovquickSearchR01HL070938 |