RecruitingACTRN12622001138774

Subclinical atrial fibrillation and cognitive decline in end stage renal failure

An observational study characterising subclinical atrial fibrillation and cognitive decline in individuals with end stage renal failure undergoing haemodialysis

Sponsor

University of Adelaide

Enrollment

200 participants

Start Date

Sep 19, 2023

Study Type

Observational

Conditions

Subclinical Atrial Fibrillation Cognitive Decline

Summary

The SCARF study will be an observational prospective study conducted over a period of three years.Our primary endpoint is the development of SCAF in these participants defined as ‘the incidence of asymptomatic atrial fibrillation’, lasting at least 30 seconds, as diagnosed by a AliveCor KardiaMobile ECG [AliveCor Inc., Mountain View, Calif, US], and previously not documented during the clinical history of the participants. Our primary endpoint is defined as ‘SCAF’ and will be assessed across 10 haemodialysis sessions using 6-lead ECG monitoring via the KardiaMobile device of the enrolled study participants (at beginning of haemodialysis session, at 1.5 and 2.5 hours into the haemodialysis. and at the end of the haemodialysis session). Additional ECGs (via the Kardia Mobile device) will be taken should the participants complain of palpitations during the haemodialysis. Should AF be detected on the basis of symptoms in these participants, it will be defined as “Symptomatic Atrial Fibrillation”. Participants enrolled in the study will be on regular maintenance haemodialysis, therefore we plan to screen participants for at least 10 haemodialysis sessions to increase the sensitivity of detecting SCAF. Secondary endpoints will be assessed using data collected from clinical records, the administration of widely used cognitive test, via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

Eligibility

Sex: MalesMin Age: 18 Yearss

Inclusion Criteria3

Participants 18 years or over who have been diagnosed with Chronic Kidney Disease (CKD) for at least three months and are on regular haemodialysis for ESRF.
Understanding of written and verbal English.
Ability to provide informed consent.

Exclusion Criteria9

Age < 18 years
Previously diagnosed AF
Valvular severe mitral valve disease
Long-term oral anticoagulant use
Alzheimers disease
Aphasia
Severe psychiatric disorders e.g. schizophrenia, schizoaffective disorder or bipolar disorder
Pregnancy
An inability to provide informed consent

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Interventions

Our study protocol will involve data collection from participant assessment, clinical reports, and the administration of researcher-led interviews and cognitive assessment. The study population will include adult patients (>18 years) on maintenance haemodialysis for chronic kidney disease. Demographic and clinical data will be collected through patient interviews and medical records. Each patient will have four ECGs taken using the AliveCor Kardia Mobile device: first- immediately before haemodialysis, Second and third- 1.5 hours and 2.5 hours into the haemodialysis, fourth- immediately after the end of haemodialysis session. For the ECG recording, the participant will place his fingers on the Kardia Mobile device and bring it in contact with his/her left knee giving a record of six-lead ECGs. This will be under guidance of a nursing personnel/ research team member. The ECGs will be interpreted by cardiologists. The anticipated duration of each ECG procedures is 30-60 seconds. Each participant will be monitored for 10 haemodialysis sessions (40 ECGs for each individual). Those found to have subclinical atrial fibrillation (SCAF) through these ECGs will be included in the study group while those without will be treated as controls. In addition, a cognitive assessment and quality of life survey will be done through researcher-led assessments {Repeatable Battery for Assessment of Neuropsychological Status, the RBANS for cognitive function; The Atrial Fibrillation Effect on QualiTy-of-life Questionnaire (AFEQT) and Short Form (SF-36) for quality of life assessment)}. The assessments will be carried out by members of the research team at the end of the 10 sessions of haemodialysis for each participant. The cognitive & quality of assessments are antcipated to take 30-45 minutes for each participant. The overall duration of observation will be the maximum time taken for each participant to complete 10 haemodialysis session which is anticipated to be 3-4 weeks.