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CompletedNCT02014792Updated Nov 6, 2020

Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

An observational study in Chronic Kidney Disease, sponsored by King's College London. Completed at 3 sites in United Kingdom. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by King's College London · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
52
Ages
40 Years to 80 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Haemodialysis
  • Heart rate variability
  • n-3 PUFA
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 52 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have recently commenced haemodialysis treatment.

Inclusion criteria

  • CKD stage 5 commencing haemodialysis,
  • male or female,
  • aged 40-80 y,
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • history of chronic liver disease or neuropathy, infection or antibiotics within the last month.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
52 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)

    Primary independent variable

    Time frame: 6-10 wk after commencing haemodialysis treatment

  2. 24 hour heart rate variability (Triangular index and SDNN)

    Primary dependent variables. Triangular index and SDNN are indicators of overall variability

    Time frame: 6-10 weeks after commencing haemodialysis treatment

Secondary outcomes

  1. 24 h heart rate variability - longer phase parameters

    Parameters of longer phase HRV: LF, VLF and SDANN

    Time frame: 6-10 weeks after commencing haemodialysis

  2. 24 h heart rate variability - short-phase parameters

    RMSSD, pNN50, HF

    Time frame: 6-10 weeks after commencing haemodialysis

  3. Nocturnal heart rate variability - all parameters

    SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time

    Time frame: 6-10 weeks after commencing haemodialysis

  4. Plasma EPA+DHA content (% weight of total fatty acids)

    Time frame: 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis

Other outcomes

  1. Complications of haemodialysis in first 6 weeks of starting treatment

    Incidence of problems with dialysis access, inadequate urea reduction ratio, amount of excess oedematous fluid removed, serious adverse events

    Time frame: 0-6 weeks after commencing haemodialysis

  2. Background dietary intakes

    Food frequency questionnaire

    Time frame: 6-10 weeks after commencing haemodialysis

  3. History of sleep apnoea

    Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history

    Time frame: 6-10 weeks after commencing haemodialysis

  4. Weight

    Time frame: 6-10 weeks after commencing haemodialysis

  5. Waist circumference

    Time frame: 6-10 weeks after commencing haemodialysis

  6. 12 month average blood pressure

    Time frame: 12 months prior to commencing haemodialysis treatment

  7. Plasma lipids

    Time frame: 6-10 weeks after commencing haemodialysis

  8. C-reactive protein

    Time frame: 6-10 weeks after commencing haemodialysis

  9. Serum electrolytes

    Sodium, potassium, calcium, phosphate

    Time frame: 6-10 weeks after commencing haemodialysis

07

Study locations

3 sites
  • King's College London
    London, SE1 9NH, United Kingdom
  • King's College Hospital
    London, SE5 9RS, United Kingdom
  • Guy's and St Thomas' Hospital
    London, United Kingdom
08

References and documents

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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02014792
Lead sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
Responsible party
Dr Wendy Hall (Lecturer in Nutritional Sciences, King's College London) — Principal investigator
First posted
Dec 18, 2013
Start date
Aug 2014
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Nov 6, 2020

Study contacts

Wendy Hall, PhD
principal investigator · King's College London
Iain Macdougall, FRCP
study chair · King's College Hospital NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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