Clinical trial NCT02014792: Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients
Official title: Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Haemodialysis
Heart rate variability
n-3 PUFA
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2013-12-18
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)
timeFrame: 6-10 wk after commencing haemodialysis treatment
measure: 24 hour heart rate variability (Triangular index and SDNN)
timeFrame: 6-10 weeks after commencing haemodialysis treatment
Secondary outcomes:
measure: 24 h heart rate variability - longer phase parameters
timeFrame: 6-10 weeks after commencing haemodialysis
measure: 24 h heart rate variability - short-phase parameters
timeFrame: 6-10 weeks after commencing haemodialysis
measure: Nocturnal heart rate variability - all parameters
timeFrame: 6-10 weeks after commencing haemodialysis
measure: Plasma EPA+DHA content (% weight of total fatty acids)
timeFrame: 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis
Other outcomes:
measure: Complications of haemodialysis in first 6 weeks of starting treatment
timeFrame: 0-6 weeks after commencing haemodialysis
measure: Background dietary intakes
timeFrame: 6-10 weeks after commencing haemodialysis
measure: History of sleep apnoea
timeFrame: 6-10 weeks after commencing haemodialysis
measure: Weight
timeFrame: 6-10 weeks after commencing haemodialysis
measure: Waist circumference
timeFrame: 6-10 weeks after commencing haemodialysis
measure: 12 month average blood pressure
timeFrame: 12 months prior to commencing haemodialysis treatment
measure: Plasma lipids
timeFrame: 6-10 weeks after commencing haemodialysis
measure: C-reactive protein
timeFrame: 6-10 weeks after commencing haemodialysis
measure: Serum electrolytes
timeFrame: 6-10 weeks after commencing haemodialysis
Locations:
city: London
country: United Kingdom
facility: King's College London
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
Study officials:
affiliation: King's College London
name: Wendy Hall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College Hospital NHS Trust
name: Iain Macdougall, FRCP
role: STUDY_CHAIR
References:
citation: 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