Chronic Kidney Disease on HemodialysisNCT02754986
Quantification of Autonomic Nervous Activity During Hemodialysis
A study testing Analysis of the holter electrocardiogram in people with Chronic Kidney Disease on Hemodialysis, run by University of Hyogo at 1 site in Japan.
Trial summary
This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation. Read more about this study
- Who is it for?
- Ages Up to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease on Hemodialysis
- What is being tested?
- Analysis of the holter electrocardiogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Aug 2015
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.
Who cannot join
- Patients with chronic atrial fibrillation
- Patients with frequent ventricular premature beats
- Patients with a permanent pacemaker
- Patients with taking antihypertensive drugs
- Patients with medical treatment due to changes in blood pressure
Trial locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Applied Informatics, University of Hyogo
Kobe, Hyōgo, 650-0047
About this study
Official title: Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis
This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.
Read the detailed description
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session.
The subjects will be divided into 3 groups, those with UFR < 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and >15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Being tested
- Analysis of the holter electrocardiogram
- Keywords
- heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the holter electrocardiogramOther
Also called Analysis of heart rate variability with using holter electrocardiogram
| Study group | Role | What they receive |
|---|---|---|
| measuring Holter electrocardiogram | Experimental | Hotter ECG will be recorded continuously during hemodialysis Receives: Other: Analysis of the holter electrocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session.
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease on HemodialysisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hyogo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiro Tsuji, University of Hyogo
- Investigators
- Yuko Mizuno-Matsumoto, Ph.D., Study director, Graduate School of Applied Informatics, University of Hyogo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754986
- Sponsor's protocol ID
- UHyogo
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Autonomic Nervous Activity by Heart Rate Variability and Approximate Entropy in High Ultrafiltration Rate During Hemodialysis
- ClinicalTrials.gov ID
- NCT02754986
- Acronym / sponsor ID
- UHyogo
- Conditions
- Chronic Kidney Disease on Hemodialysis
- Keywords
- heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of HyogoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- First posted
- 28 Apr 2016 (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.
This study assesses autonomic nervous system function by power spectral analysis of RR interval dynamics in ultrafiltration subjects without blood pressure variation.
Detailed description
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability in hemodialysis patients without blood pressure variations during HD session.
The subjects will be divided into 3 groups, those with UFR < 10 ml/hr/kg; ≥10 ml/hr/kg but ≤ 15 ml/hr/kg; and >15 ml/hr/kg, and Holter ECG are recorded continuously during HD session using frequency analysis of RR intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measuring Holter electrocardiogram | Experimental | Other: Analysis of the holter electrocardiogramHotter ECG will be recorded continuously during hemodialysis |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with stable undergoing hemodialysis without hanging in blood pressure during hemodialysis.
Key exclusion criteria (5 listed)
- Patients with chronic atrial fibrillation
- Patients with frequent ventricular premature beats
- Patients with a permanent pacemaker
- Patients with taking antihypertensive drugs
- Patients with medical treatment due to changes in blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of the holter electrocardiogramAlso: Analysis of heart rate variability with using holter electrocardiogram | Other | measuring Holter electrocardiogram |
Primary outcome
The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session.
Time frame: 4 hours
Variations over time in autonomic nervous activity due to differences in ultrafiltration rate will be evaluated by measuring heart rate variability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: Yes
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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.
Yuko Mizuno-Matsumoto, Ph.D. study director
Graduate School of Applied Informatics, University of Hyogo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of the holter electrocardiogram in people with Chronic Kidney Disease on Hemodialysis, run by University of Hyogo at 1 site in Japan.
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 5 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: finished, as of the sponsor's last update on 28 Apr 2016. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The outcome measures was low frequency power (LF, ms2) to high frequency power (HF, ms2) ratio (LF/HF ratio) of heart rate variability. The three subject groups with difference ultrafiltration were compared by LF/HF ratio during hemodialysis session. (time frame: 4 hours). 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 28 Apr 2016.