Chronic Kidney DiseaseNCT00824577
Heart Rate Variability in Chronic Kidney Disease Patients
An observational study of Chronic Kidney Disease and Heart Rate Variability, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Chronic Kidney Disease, Heart Rate Variability
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Sep 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: peritoneal dialysis: peritoneal dialysis patient lasting for more than 3 months
Who may be able to join
- peritoneal dialysis more than 3 months
Who cannot join
- pregnancy 2. received CT in recent 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients
Read the 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.
- Conditions
- Chronic Kidney Disease, Heart Rate Variability
- Keywords
- heart rate variability, autonomic function, heart function
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 250~300 patients | heart rate variability, heart function and Kt/V |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability, heart function, PET, Kt/V
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824577
- Sponsor's protocol ID
- 200812010R
- Status last verified
- Jun 2010
- First submitted
- 16 Jan 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT00824577
- Acronym / sponsor ID
- 200812010R
- Conditions
- Chronic Kidney Disease, Heart Rate Variability
- Keywords
- heart rate variability, autonomic function, heart function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use 24hr Holter ECG, ultrasound and cardiac fibrosis markers in the chronic kidney disease patients
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 250~300 patients | – | –heart rate variability, heart function and Kt/V |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- peritoneal dialysis: peritoneal dialysis patient lasting for more than 3 months
Key inclusion criteria (1 listed)
- peritoneal dialysis more than 3 months
Key exclusion criteria (1 listed)
- pregnancy 2. received CT in recent 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
heart rate variability, heart function, PET, Kt/V
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Heart Rate Variability, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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.
What does the primary outcome measure?
heart rate variability, heart function, PET, Kt/V (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2010.