Role of Chronic Kidney Disease in Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00069810
Recruitment Status : Withdrawn (The study is not a clinical trial.)
First Posted : October 6, 2003
Last Update Posted : April 6, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Washington

Brief Summary:
The purpose of this study is to determine how the progressive loss of kidney function influences cardiovascular disease.

Condition or disease
Cardiovascular Diseases Heart Diseases Kidney Failure, Chronic

Detailed Description:


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 370,000 prevalent ESRD patients, which was expected to grow to 610,000 by the year 2010. Furthermore, the adjusted death rate for all incident ESRD patients was 19.8 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 10.9 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 nation's 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.


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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress in Chronic Kidney Disease
Study Start Date : August 2003
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Biospecimen Retention:   Samples With DNA
EDTA tube of whole blood

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People with chronic kidney disease and healthy subjects

Inclusion Criteria:

  • Mentally competent and willing to sign the consent form
  • Agree to follow up with our nephrology clinic every 3 months for 3 years
  • Agree to have the carotid Doppler studies, transthoracic echocardiogram, and brachial artery Doppler measurements

Exclusion Criteria:

  • Do not wish to participate
  • Acute inflammatory illness
  • On experimental drug protocols
  • Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin
  • Pregnant women
  • Atrial fibrillation (only for those undergoing pulse wave velocity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069810

Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jonathan Himmelfarb, MD Harborview Injury Prevention and Research Center

Responsible Party: Jonathan Himmelfarb, MD, Harborview Medical Center Identifier: NCT00069810     History of Changes
Other Study ID Numbers: 1234
R01HL070938 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2003    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Heart Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases