Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)	Primary independent variable	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	6-10 weeks after commencing haemodialysis treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 h heart rate variability - longer phase parameters	Parameters of longer phase HRV: LF, VLF and SDANN	6-10 weeks after commencing haemodialysis
24 h heart rate variability - short-phase parameters	RMSSD, pNN50, HF	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	6-10 weeks after commencing haemodialysis
Plasma EPA+DHA content (% weight of total fatty acids)		6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-6 weeks after commencing haemodialysis
Background dietary intakes	Food frequency questionnaire	6-10 weeks after commencing haemodialysis
History of sleep apnoea	Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history	6-10 weeks after commencing haemodialysis
Weight		6-10 weeks after commencing haemodialysis
Waist circumference		6-10 weeks after commencing haemodialysis
12 month average blood pressure		12 months prior to commencing haemodialysis treatment
Plasma lipids		6-10 weeks after commencing haemodialysis
C-reactive protein		6-10 weeks after commencing haemodialysis
Serum electrolytes	Sodium, potassium, calcium, phosphate	6-10 weeks after commencing haemodialysis

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King's College Hospital NHS Trust
• Investigators: Study Chair: Iain Macdougall, FRCP, King's College Hospital NHS Trust

Publications and helpful links

General 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

Helpful Links

• Abstract (13th European Nutrition Conference, FENS 2019, 15-18 October 2019, Malnutrition in an Obese World: European Perspectives)

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Actual): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: n-3 PUFA; Heart rate variability; Haemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: DNS9195677