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NCT00824577 Clinical Trial

Heart Rate Variability in Chronic Kidney Disease Patients

Chronic Kidney Disease Clinical Trial

Official title:
Heart Rate Variability in Chronic Kidney Disease Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00824577
Other study ID # 200812010R
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 16, 2009
Last updated June 28, 2010
Start date December 2009
Est. completion date September 2010

Study information
Verified date June 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date September 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 90 Years
Eligibility Inclusion Criteria:

- peritoneal dialysis more than 3 months

Exclusion Criteria:

- pregnancy 2. received CT in recent 3 months

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate variability, heart function, PET, Kt/V 12 months Yes
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