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Completed

NCT Number: NCT02014792

Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guy's and St Thomas' Hospital, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)

    Time frame: 6-10 wk after commencing haemodialysis treatment

    Primary independent variable

  2. 24 hour heart rate variability (Triangular index and SDNN)

    Time frame: 6-10 weeks after commencing haemodialysis treatment

    Primary dependent variables. Triangular index and SDNN are indicators of overall variability

Secondary outcomes

  1. 24 h heart rate variability - longer phase parameters

    Time frame: 6-10 weeks after commencing haemodialysis

    Parameters of longer phase HRV: LF, VLF and SDANN

  2. 24 h heart rate variability - short-phase parameters

    Time frame: 6-10 weeks after commencing haemodialysis

    RMSSD, pNN50, HF

  3. Nocturnal heart rate variability - all parameters

    Time frame: 6-10 weeks after commencing haemodialysis

    SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time

  4. Plasma EPA+DHA content (% weight of total fatty acids)

    Time frame: 6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis

Other outcomes

  1. Complications of haemodialysis in first 6 weeks of starting treatment

    Time frame: 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

  2. Background dietary intakes

    Time frame: 6-10 weeks after commencing haemodialysis

    Food frequency questionnaire

  3. History of sleep apnoea

    Time frame: 6-10 weeks after commencing haemodialysis

    Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history

  4. Weight

    Time frame: 6-10 weeks after commencing haemodialysis

  5. Waist circumference

    Time frame: 6-10 weeks after commencing haemodialysis

  6. 12 month average blood pressure

    Time frame: 12 months prior to commencing haemodialysis treatment

  7. Plasma lipids

    Time frame: 6-10 weeks after commencing haemodialysis

  8. C-reactive protein

    Time frame: 6-10 weeks after commencing haemodialysis

  9. Serum electrolytes

    Time frame: 6-10 weeks after commencing haemodialysis

    Sodium, potassium, calcium, phosphate

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • King's College Hospital NHS Trust

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 18, 2013
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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