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NCT02014792 Clinical Trial

Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02014792
Other study ID # DNS9195677
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2014
Est. completion date March 2016

Study information
Verified date November 2020
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom Guy's and St Thomas' Hospital London
United Kingdom King's College Hospital London
United Kingdom King's College London London

Sponsors (2)
Lead Sponsor Collaborator
King's College London King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Other 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
Other Background dietary intakes Food frequency questionnaire 6-10 weeks after commencing haemodialysis
Other History of sleep apnoea Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history 6-10 weeks after commencing haemodialysis
Other Weight 6-10 weeks after commencing haemodialysis
Other Waist circumference 6-10 weeks after commencing haemodialysis
Other 12 month average blood pressure 12 months prior to commencing haemodialysis treatment
Other Plasma lipids 6-10 weeks after commencing haemodialysis
Other C-reactive protein 6-10 weeks after commencing haemodialysis
Other Serum electrolytes Sodium, potassium, calcium, phosphate 6-10 weeks after commencing haemodialysis
Primary Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids) Primary independent variable 6-10 wk after commencing haemodialysis treatment
Primary 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 24 h heart rate variability - longer phase parameters Parameters of longer phase HRV: LF, VLF and SDANN 6-10 weeks after commencing haemodialysis
Secondary 24 h heart rate variability - short-phase parameters RMSSD, pNN50, HF 6-10 weeks after commencing haemodialysis
Secondary 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
Secondary Plasma EPA+DHA content (% weight of total fatty acids) 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis
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