Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001138774
Ethics application status
Approved
Date submitted
4/08/2022
Date registered
18/08/2022
Date last updated
18/08/2022
Date data sharing statement initially provided
18/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Subclinical atrial fibrillation and cognitive decline in end stage renal failure
Scientific title
An observational study characterising subclinical atrial fibrillation and cognitive decline in individuals with end stage renal failure undergoing haemodialysis
Secondary ID [1] 307711 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SCARF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subclinical Atrial Fibrillation 327271 0
End Stage Renal Failure 327272 0
Cognitive Decline 327273 0
Condition category
Condition code
Cardiovascular 324405 324405 0 0
Other cardiovascular diseases
Renal and Urogenital 324415 324415 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 324188 0
Early Detection / Screening
Comparator / control treatment
Participants not detected with subclinical atrial fibrillation during ECG monitoring will be part of the control group. They will undergo the SF-36 questionnaire and the RBANS for assessment of quality of life and cognitive function respectively.
Control group
Active

Outcomes
Primary outcome [1] 332220 0
The primary outcome for this study is the prevalence of SCAF in participants with End Stage Renal Failure (ESRF) undergoing haemodialysis. This will be assessed by monitoring six-lead ECGs using the AliveCor Kardia Mobile.
Timepoint [1] 332220 0
End of screening for each participant (10 haemodialysis sessions)
Secondary outcome [1] 412587 0
Risk factors- haemodialysis related- for incident SCAF in participants on maintenance haemodialysis;

This will be assessed using the following clinical and laboratory data that will be collected as part of the study:

A. Pre and post dialysis weights,

B. Serum potassium (pre and post dialysis), calcium, sodium

C. Type of dialysates used specifically looking at the potassium and bicarbonate baths,

D. Type of dialysis membranes (low flux or high flux),

E. Haemodialysis versus Haemodiafiltration (predilution/postdilution),

F. Haemoglobin, Albumin, Troponin and NT pro BNP if available

G. Type of access for haemodialysis and site of the arteriovenous fistula
Timepoint [1] 412587 0
End of screening for each participant (10 haemodialysis sessions)
Secondary outcome [2] 412610 0
Risk factors- haemodialysis unrelated- for incident SCAF in participants on maintenance haemodialysis.

This will be assessed using the following data that will be collected as part of the study: Hypertension, Diabetes mellitus, Coronary artery disease, history of cerebrovascular accident, peripheral vascular disease, smoking, dyslipidemia, hyperthyroidism
Timepoint [2] 412610 0
End of screening for each participant (10 haemodialysis sessions)
Secondary outcome [3] 412613 0
Cognitive function associated with SCAF compared to participants without SCAF.

Cognitive function will be studies using the RBANS tool and then compared between the study group (detected as having SCAF) and the control group (not detected as having SCAF).
Timepoint [3] 412613 0
End of screening for each participant (10 haemodialysis sessions)
Secondary outcome [4] 412614 0
Quality of Life in Patients with SCAF compared to those without SCAF.

This will be done using standard questionnaires administered to both groups {Short Form (SF-36) for quality of life assessment}.
Timepoint [4] 412614 0
End of screening for each participant (10 haemodialysis sessions)
Secondary outcome [5] 413103 0
Quality of Life in participants with SCAF.

This will be done using the Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT).
Timepoint [5] 413103 0
End of screening for each participant (10 haemodialysis sessions)

Eligibility
Key inclusion criteria
• 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• 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

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311985 0
University
Name [1] 311985 0
University of Adelaide
Country [1] 311985 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Faculty of Health and Medical Sciences
University of Adelaide
North Terrace,
Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 313469 0
None
Name [1] 313469 0
Address [1] 313469 0
Country [1] 313469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311408 0
Central Adelaide Local Health Network
Ethics committee address [1] 311408 0
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 311408 0
Australia
Date submitted for ethics approval [1] 311408 0
Approval date [1] 311408 0
25/07/2022
Ethics approval number [1] 311408 0

Summary
Brief 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120990 0
A/Prof Rajiv Mahajan
Address 120990 0
University of Adelaide Precinct
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 120990 0
Australia
Phone 120990 0
+61 881829439
Fax 120990 0
Email 120990 0
rajiv.mahajan@adelaide.edu.au
Contact person for public queries
Name 120991 0
A/Prof Rajiv Mahajan
Address 120991 0
University of Adelaide Precinct
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 120991 0
Australia
Phone 120991 0
+61 881829439
Fax 120991 0
Email 120991 0
rajiv.mahajan@adelaide.edu.au
Contact person for scientific queries
Name 120992 0
A/Prof Rajiv Mahajan
Address 120992 0
University of Adelaide Precinct
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 120992 0
Australia
Phone 120992 0
+61 881829439
Fax 120992 0
Email 120992 0
rajiv.mahajan@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.