Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT02014792
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2013-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood Plasma Washed and isolated red blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-12-12', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications of haemodialysis in first 6 weeks of starting treatment', 'timeFrame': '0-6 weeks after commencing haemodialysis', 'description': 'Incidence of problems with dialysis access, inadequate urea reduction ratio, amount of excess oedematous fluid removed, serious adverse events'}, {'measure': 'Background dietary intakes', 'timeFrame': '6-10 weeks after commencing haemodialysis', 'description': 'Food frequency questionnaire'}, {'measure': 'History of sleep apnoea', 'timeFrame': '6-10 weeks after commencing haemodialysis', 'description': 'Epworth Sleepiness scale and Berlin questionnaire, plus relevant medical history'}, {'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', 'description': 'Sodium, potassium, calcium, phosphate'}], 'primaryOutcomes': [{'measure': 'Erythrocyte eicsapentaenoic acid (EPA) + docosahexaenoic acid (DHA) content (% weight of total fatty acids)', 'timeFrame': '6-10 wk after commencing haemodialysis treatment', 'description': 'Primary independent variable'}, {'measure': '24 hour heart rate variability (Triangular index and SDNN)', 'timeFrame': '6-10 weeks after commencing haemodialysis treatment', 'description': 'Primary dependent variables. Triangular index and SDNN are indicators of overall variability'}], 'secondaryOutcomes': [{'measure': '24 h heart rate variability - longer phase parameters', 'timeFrame': '6-10 weeks after commencing haemodialysis', 'description': 'Parameters of longer phase HRV: LF, VLF and SDANN'}, {'measure': '24 h heart rate variability - short-phase parameters', 'timeFrame': '6-10 weeks after commencing haemodialysis', 'description': 'RMSSD, pNN50, HF'}, {'measure': 'Nocturnal heart rate variability - all parameters', 'timeFrame': '6-10 weeks after commencing haemodialysis', 'description': 'SDNN, Triangular index, LF, HF, VLF, SDANN, RMSSD, pNN50 calculating during nocturnal sleep-time'}, {'measure': 'Plasma EPA+DHA content (% weight of total fatty acids)', 'timeFrame': '6-10 weeks after commencing haemodialysis6-10 weeks after commencing haemodialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemodialysis', 'Heart rate variability', 'n-3 PUFA'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'type': 'RESULT', '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'}], 'seeAlsoLinks': [{'url': 'http://www.cambridge.org/core/journals/proceedings-of-the-nutrition-society/article/heart-rate-variability-and-long-chain-n3-pufa-in-patients-with-chronic-kidney-disease-commencing-haemodialysis-a-crosssectional-study/8AFEC1E1F7F909C3E8840868C8E5BECA', 'label': 'Abstract (13th European Nutrition Conference, FENS 2019, 15-18 October 2019, Malnutrition in an Obese World: European Perspectives)'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients attending King's College Hospital and Guy's and St Thomas' Hospitals who have recently commenced haemodialysis treatment.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD stage 5 commencing haemodialysis,\n* male or female,\n* aged 40-80 y,\n* written informed consent\n\nExclusion Criteria:\n\n* history of chronic liver disease or neuropathy, infection or antibiotics within the last month.'}, 'identificationModule': {'nctId': 'NCT02014792', 'briefTitle': 'Heart Rate Variability & Fatty Acid Status: Haemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Heart Rate Variability and Omega-3 Fatty Acid Status in Haemodialysis Patients: an Observational Pilot Study', 'orgStudyIdInfo': {'id': 'DNS9195677'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic kidney disease, stage 5', 'description': 'Patients with stage 5 chronic kidney disease who have recently commenced haemodialysis treatment (within 6-10 weeks of starting treatment)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Wendy Hall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}, {'name': 'Iain Macdougall, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': "King's College Hospital NHS Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Nutritional Sciences', 'investigatorFullName': 'Dr Wendy Hall', 'investigatorAffiliation': "King's College London"}}}}