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Cardiovascular DiseasesNCT00069810

Role of Chronic Kidney Disease in Cardiovascular Disease

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2003to Dec 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: People with chronic kidney disease and healthy subjects

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

Official title: Oxidative Stress in Chronic Kidney Disease

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

Read the 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.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Kidney Failure, Chronic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2003 (estimated)
  2. Study startAug 2003
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Why it stopped: The study is not a clinical trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069810
Sponsor's protocol ID
1234
Other IDs
R01HL070938
Status last verified
Apr 2017
First submitted
1 Oct 2003
Last updated
6 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • Simmons EM, Langone A, Sezer MT, Vella JP, Recupero P, Morrow JD, Ikizler TA, Himmelfarb J. Effect of renal transplantation on biomarkers of inflammation and oxidative stress in end-stage renal disease patients. Transplantation. 2005 Apr 27;79(8):914-9. doi: 10.1097/01.tp.0000157773.96534.29.

    PubMed 15849543

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069810, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.

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