Role of Chronic Kidney Disease in Cardiovascular Disease

This study has been withdrawn prior to enrollment.
(The study is not a clinical trial.)
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00069810
First received: October 1, 2003
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

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


Condition
Cardiovascular Diseases
Heart Diseases
Kidney Failure, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Stress in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA

EDTA tube of whole blood


Estimated Enrollment: 200
Study Start Date: August 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People with chronic kidney disease and healthy subjects

Criteria

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)
  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: NCT00069810

Sponsors and Collaborators
Investigators
Principal Investigator: Jonathan Himmelfarb, MD Harborview Injury Prevention and Research Center
  More Information

Publications:
Responsible Party: Jonathan Himmelfarb, MD, Harborview Medical Center
ClinicalTrials.gov Identifier: NCT00069810     History of Changes
Other Study ID Numbers: 1234, R01 HL70938
Study First Received: October 1, 2003
Last Updated: July 16, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014