Heart Rate Variability in Chronic Kidney Disease Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00824577
First received: January 16, 2009
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients


Condition
Chronic Kidney Disease
Heart Rate Variability

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Heart Rate Variability in Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • heart rate variability, heart function, PET, Kt/V [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

PD effluent and blood sample


Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
250~300 patients
heart rate variability, heart function and Kt/V

Detailed Description:

24hr Holter examination is a non-invasive tool in detecting and diagnosing cardiac arrhythmia. Moreover, Heart rate variability has been proven to been an important prognostic factor in many cardiovascular diseases. The traditional linear analysis of heart rate variability proved to predict clinical outcome in myocardial infarction patients. The more delicate non-linear analysis in heart rate variability is one of the hot topics in the world.

Despite some biochemical values like WBC counts, platelet counts, BUN, creatinine, lactate, clinical vital parameters like blood pressure, heart rate, and oxygenation have been used to predict clinical outcome in chronic renal disease(CKD) patients, the application is still limited. It is an international interest to find a more safe and simple technique to identify important prognostic factors in CKD patients. Our project aimed to recruit these CKD patients from our hospital and conduct a cross-sectional study. Cardiac ultrasonography and 24hrs Holter will be arranged. Linear and non-linear analysis of heart rate variability will be performed and serum marker that influence prognosis like WBC count, platelet count, lactate, BUN, creatinine, fibrosis marker and adiponectin will be checked. Short term and long term outcome was followed and identify important prognostic factors to improve and detect clinical prognosis.

  Eligibility

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

peritoneal dialysis: peritoneal dialysis patient lasting for more than 3 months

Criteria

Inclusion Criteria:

  • peritoneal dialysis more than 3 months

Exclusion Criteria:

  • pregnancy 2. received CT in recent 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824577

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Jenq-Wen Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00824577     History of Changes
Other Study ID Numbers: 200812010R
Study First Received: January 16, 2009
Last Updated: June 28, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
heart rate variability
autonomic function
heart function

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

ClinicalTrials.gov processed this record on June 17, 2013