Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT02014792
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Plasma EPA+DHA content (% weight of total fatty acids)	6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis
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

Trial Locations

Locations (3)

King's College London; 🇬🇧 London, United Kingdom

King's College Hospital; 🇬🇧 London, United Kingdom

Guy's and St Thomas' Hospital; 🇬🇧 London, United Kingdom