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The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01945255
First received: September 9, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. Uremic patients also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in HD patients, are needed for future management and preventions of CV related morbidity and mortality.


Condition
End-stage Renal Disease
Hemodialysis
Aortic Calcification
Peripheral Artery Occlusion
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Evaluate the associations between aortic pulse wave, ankle-brachial index, and blood/serum biochemical markers, such as MPO, MMP-9, IL-6, adiponectin, TNF-alpha, of the patients in prevalent hemodialysis patients. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
HD-ABI
  1. Patients at National Taiwan University Hospital (NTUH)
  2. Patients who have received PD more than 3 months
  3. Patients who sign the informed consents
  4. Patients who aged between 20-90 years

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HD patients

Criteria

Inclusion Criteria:

  1. Patients at National Taiwan University Hospital (NTUH)
  2. patients who have received HD more than 3 months
  3. Patients who sign the informed consents

Exclusion Criteria:

  1. Patients who refuse to sign informed consents
  2. Patients who refuse to draw additional blood for research
  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: NCT01945255

Contacts
Contact: Jenq-Wen Huang, Doctor +886-2-2312-3456 ext 63288 007378@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital (NTUH) Recruiting
Taipei, Taiwan, 10002
Contact: Jenq-Wen Huang, Doctor    +886-2-2312-3456 ext 63288    007378@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01945255     History of Changes
Other Study ID Numbers: 201112007RIC
Study First Received: September 9, 2013
Last Updated: April 11, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Calcification
aortic pulse wave velocity
peripheral artery occlusion disease
hemodialysis
metabolic syndrome

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Calcinosis
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014