NCT02014792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

December 12, 2013

Last Update Submit

November 4, 2020

Conditions

Chronic Kidney Disease

Keywords

HaemodialysisHeart rate variabilityn-3 PUFA

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 24 h heart rate variability - longer phase parameters

    6-10 weeks after commencing haemodialysis

  • 24 h heart rate variability - short-phase parameters

    6-10 weeks after commencing haemodialysis

  • Nocturnal heart rate variability - all parameters

    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 Outcomes (9)

  • Complications of haemodialysis in first 6 weeks of starting treatment

    0-6 weeks after commencing haemodialysis

  • Background dietary intakes

    6-10 weeks after commencing haemodialysis

  • History of sleep apnoea

    6-10 weeks after commencing haemodialysis

  • +6 more other outcomes

Study Arms (1)

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)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have recently commenced haemodialysis treatment.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

King's College London

London, SE1 9NH, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Guy's and St Thomas' Hospital

London, United Kingdom

Location

Related 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:10.1017/S0029665120005923

    RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma Washed and isolated red blood cells

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wendy Hall, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

  • Iain Macdougall, FRCP

    King's College Hospital NHS Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Nutritional Sciences

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 18, 2013

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

GB(3)