Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02014792

Enrollment

Registered

2013-12-18

Start date

2014-08-31

Completion date

2016-03-31

Last updated

2020-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Haemodialysis, Heart rate variability, n-3 PUFA

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)	6-10 wk after commencing haemodialysis treatment	Primary independent variable
24 hour heart rate variability (Triangular index and SDNN)	6-10 weeks after commencing haemodialysis treatment	Primary dependent variables. Triangular index and SDNN are indicators of overall variability

Secondary

Measure	Time frame	Description
24 h heart rate variability - longer phase parameters	6-10 weeks after commencing haemodialysis	Parameters of longer phase HRV: LF, VLF and SDANN
24 h heart rate variability - short-phase parameters	6-10 weeks after commencing haemodialysis	RMSSD, pNN50, HF
Nocturnal heart rate variability - all parameters	6-10 weeks after commencing haemodialysis	SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time
Plasma EPA+DHA content (% weight of total fatty acids)	6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis	—

Other

Measure	Time frame	Description
12 month average blood pressure	12 months prior to commencing haemodialysis treatment	—
Serum electrolytes	6-10 weeks after commencing haemodialysis	Sodium, potassium, calcium, phosphate
C-reactive protein	6-10 weeks after commencing haemodialysis	—
Plasma lipids	6-10 weeks after commencing haemodialysis	—
Complications of haemodialysis in first 6 weeks of starting treatment	0-6 weeks after commencing haemodialysis	Incidence of problems with dialysis access, inadequate urea reduction ratio, amount of excess oedematous fluid removed, serious adverse events
Background dietary intakes	6-10 weeks after commencing haemodialysis	Food frequency questionnaire
History of sleep apnoea	6-10 weeks after commencing haemodialysis	Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history
Weight	6-10 weeks after commencing haemodialysis	—
Waist circumference	6-10 weeks after commencing haemodialysis	—

Countries

United Kingdom

Outcome results