Chronic Kidney DiseaseNCT02014792
Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients
An observational study of Chronic Kidney Disease, run by King's College London at 3 sites in United Kingdom.
Trial summary
Studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated with increased risk of sudden cardiac death (SCD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 52 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2014to Mar 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have recently commenced haemodialysis treatment.
Who may be able to join
- CKD stage 5 commencing haemodialysis,
- male or female,
- aged 40-80 y,
- written informed consent
Who cannot join
- history of chronic liver disease or neuropathy, infection or antibiotics within the last month.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
King's College London
London, SE1 9NH
King's College Hospital
London, SE5 9RS
Guy's and St Thomas' Hospital
London
About this study
Official title: Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study
Studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated with increased risk of sudden cardiac death (SCD). The purpose of this research is to investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid levels in patients who have recently commenced haemodialysis.
- Conditions
- Chronic Kidney Disease
- Keywords
- Haemodialysis, Heart rate variability, n-3 PUFA
- 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 |
|---|---|---|
| Chronic kidney disease, stage 5 | Patients with stage 5 chronic kidney disease who have recently commenced haemodialysis treatment (within 6-10 weeks of starting treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)
Primary independent variable
Measured: 6-10 wk after commencing haemodialysis treatment
24 hour heart rate variability (Triangular index and SDNN)
Primary dependent variables. Triangular index and SDNN are indicators of overall variability
Measured: 6-10 weeks after commencing haemodialysis treatment
Secondary outcomes (4)
24 h heart rate variability - longer phase parameters
Parameters of longer phase HRV: LF, VLF and SDANN
Measured: 6-10 weeks after commencing haemodialysis
24 h heart rate variability - short-phase parameters
RMSSD, pNN50, HF
Measured: 6-10 weeks after commencing haemodialysis
Nocturnal heart rate variability - all parameters
SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time
Measured: 6-10 weeks after commencing haemodialysis
Plasma EPA+DHA content (% weight of total fatty acids)
Measured: 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Dr Wendy Hall, King's College London
- Investigators
- Wendy Hall, PhD, Principal investigator, King's College LondonIain Macdougall, FRCP, Study chair, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014792
- Sponsor's protocol ID
- DNS9195677
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2013
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinto, A., MacLaughlin, H., Gray, R., & Hall, W. (2020). Heart rate variability and long chain n-3 PUFA in patients with chronic kidney disease commencing haemodialysis: A cross-sectional study. Proceedings of the Nutrition Society, 79(OCE2), E643. doi:10.1017/S0029665120005923
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study
- ClinicalTrials.gov ID
- NCT02014792
- Acronym / sponsor ID
- DNS9195677
- Conditions
- Chronic Kidney Disease
- Keywords
- Haemodialysis, Heart rate variability, n-3 PUFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Dec 2013 (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.
Studies suggest that dietary omega-3 fatty acids influence the extent to which the time interval between each heart beat varies (heart rate variability; HRV). Low HRV is associated with increased risk of sudden cardiac death (SCD). The purpose of this research is to investigate the relationship between 24 hour parameters of HRV and blood omega-3 fatty acid levels in patients who have recently commenced haemodialysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease, stage 5 | – | –Patients with stage 5 chronic kidney disease who have recently commenced haemodialysis treatment (within 6-10 weeks of starting treatment) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have recently commenced haemodialysis treatment.
Key inclusion criteria (4 listed)
- CKD stage 5 commencing haemodialysis,
- male or female,
- aged 40-80 y,
- written informed consent
Key exclusion criteria (1 listed)
- history of chronic liver disease or neuropathy, infection or antibiotics within the last month.
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
Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)
Time frame: 6-10 wk after commencing haemodialysis treatment
Primary independent variable
24 hour heart rate variability (Triangular index and SDNN)
Time frame: 6-10 weeks after commencing haemodialysis treatment
Primary dependent variables. Triangular index and SDNN are indicators of overall variability
4 secondary outcomes
24 h heart rate variability - longer phase parameters
Time frame: 6-10 weeks after commencing haemodialysis
24 h heart rate variability - short-phase parameters
Time frame: 6-10 weeks after commencing haemodialysis
Nocturnal heart rate variability - all parameters
Time frame: 6-10 weeks after commencing haemodialysis
Plasma EPA+DHA content (% weight of total fatty acids)
Time frame: 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis
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 6 Nov 2020.
- Results publicationPinto, A., MacLaughlin, H., Gray, R., & Hall, W. (2020). Heart rate variability and long chain n-3 PUFA in patients with chronic kidney disease commencing haemodialysis: A cross-sectional study. Proceedings of the Nutrition Society, 79(OCE2), E643. doi:10.1017/S0029665120005923
- Abstract (13th European Nutrition Conference, FENS 2019, 15-18 October 2019, Malnutrition in an Obese World: European Perspectives)Link provided by the sponsor.
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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.
Wendy Hall, PhD principal investigator
King's College London
Iain Macdougall, FRCP study chair
King's College Hospital NHS Trust
3 sites 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, run by King's College London at 3 sites in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids) (time frame: 6-10 wk after commencing haemodialysis treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02014792, which also lists 1 linked publication.
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 6 Nov 2020.