Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000520538p
Ethics application status
Submitted, not yet approved
Date submitted
10/02/2024
Date registered
26/04/2024
Date last updated
26/04/2024
Date data sharing statement initially provided
26/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening for cardiac amyloidosis in patients with newly identified conduction disease
Scientific title
Screening for cardiac amyloidosis in patients with newly identified conduction disease
Secondary ID [1] 311515 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac amylodiosis 332853 0
Condition category
Condition code
Cardiovascular 329569 329569 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screening for cardiac amyloidosis which includes a 99m Technitium-labelled pyrophosphate (PYP) scan and assessed using the Perugini scale to establish a diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM), serum free light chain assay and serum immunofixation to assess for potential amyloid light chain (AL) amyloidosis. The initial screening would be performed following pacemaker insertion, either as an inpatient during the index pacemaker admission or as an outpatient. These tests will be ordered by a member of the research team/the treating cardiology team.

The pyrophosphate scan will be performed by the Nuclear medicine department at Eastern Health. Only one pyrophosphate scan will be required and the duration of the scan is 2 hours.

The pathology tests including serum free light chain assay and serum immunofixation will be taken via blood sample through Eastern Health pathology services. The pathology test will take 15 minutes to acquire and only be required once.

all patients will undergo a transthoracic echocardiogram to assess for signs of heart failure and other features of cardiac amyloidosis including both ventricular and atrial strain. Transthoracic echocardiograms should be performed as part of the work up for all patients with conduction disease so do not represent an additional test. Transthoracic echocardiograms are non-invasive tests that do not cause any harm to the patient and do not have any side effects. They do have a 1-hour time commitment and are conducted at Box Hill hospital.
In patients with no evidence of plasma cell dyscrasia but a non-diagnostic PYP scan, there is a potential for early diagnosis of ATTR-CM with a Perugini score of 1, cardiac MRI and/or cardiac biopsy would be required on a case-by-case basis to investigate for other signs of ATTR-CM. If a cardiac MRI is required, patients will usually need to wait for 6 weeks until after their cardiac electronic implantable device is placed to be able to have a cardiac MRI. The cardiac MRI would be conducted at the Victorian Heart Hospital as Eastern Health does not have a cardiac MRI. The Cardiac MRI will take around 1 hour to complete and be performed by a Cardiologist.
Intervention code [1] 327969 0
Early detection / Screening
Comparator / control treatment
Historical analysis of a previous matched cohort of patients at same institution collected from January 2018 to December 2023.
Control group
Historical

Outcomes
Primary outcome [1] 337360 0
Diagnosis of ATTR cardiac amyloidosis
Timepoint [1] 337360 0
Immediately after all screening procedures have finished.
Secondary outcome [1] 431572 0
Presence of AL amyloidosis
Timepoint [1] 431572 0
Immediately after all screening procedures have finished.
Secondary outcome [2] 433618 0
In patients found to have ATTR cardiac amyloidosis, degree of ATTR-cardiac amyloidosis
Timepoint [2] 433618 0
Recorded at time of initial screening as pathology will be taken along with the serum protein electrophoresis and serum free light chain analysis to reduce number of blood tests required by participant.
Secondary outcome [3] 433619 0
In patients diagnosed with ATTR cardiac amyloidosis: Whether the patient as a genetic form of cardiac amyloidosis (variant ATTR) or secondary to ageing (wild type ATTR)
Timepoint [3] 433619 0
Following diagnosis of ATTR cardiac amyloidosis.
Secondary outcome [4] 434304 0
Presence of heart failure symptoms classified based on the New York Heart Association classification system.
Timepoint [4] 434304 0
At time of pacemaker insertion/during index admission.

Eligibility
Key inclusion criteria
Patients 65 or older who have new conduction disease requiring the implantation of a pacemaker.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
– Known cardiac amyloidosis.
– Patients with a clear alternative cause of conduction disease including other infiltrative cardiomyopathies, ischaemia or medication induced conduction disease.
– Patients with life expectancy < 12 months or severe comorbidities where screening would not be beneficial for the individual.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
3/08/2026
Actual
Date of last data collection
Anticipated
6/10/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26171 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 42039 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 316238 0
Hospital
Name [1] 316238 0
Eastern Health Research Grant
Country [1] 316238 0
Australia
Primary sponsor type
Hospital
Name
Box Hill Hospital
Address
Country
Australia
Secondary sponsor category [1] 317930 0
None
Name [1] 317930 0
Address [1] 317930 0
Country [1] 317930 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314662 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 314662 0
https://www.easternhealth.org.au/site/item/34-research-ethics
Ethics committee country [1] 314662 0
Australia
Date submitted for ethics approval [1] 314662 0
04/04/2024
Approval date [1] 314662 0
Ethics approval number [1] 314662 0

Summary
Brief summary
Patients with cardiac amyloidosis are known to have conduction disease, however, conduction disease is usually only identified once patients have developed overt heart failure. There is evidence to suggest that conduction disease may precede overt cardiac amyloidosis, providing an opportunity for earlier diagnosis and treatment of this condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132326 0
Dr Jithin Sajeev
Address 132326 0
Box Hill Hospital, 8 Arnold St, Box Hill, 3128 Victoria
Country 132326 0
Australia
Phone 132326 0
+61433613235
Fax 132326 0
Email 132326 0
jithinsajeev@gmail.com
Contact person for public queries
Name 132327 0
Timothy Scully
Address 132327 0
Box Hill Hospital, 8 Arnold St, Box Hill, 3128 Victoria
Country 132327 0
Australia
Phone 132327 0
+61401397550
Fax 132327 0
Email 132327 0
tgraemescully@gmail.com
Contact person for scientific queries
Name 132328 0
Timothy Scully
Address 132328 0
Box Hill Hospital, 8 Arnold St, Box Hill, 3128 Victoria
Country 132328 0
Australia
Phone 132328 0
+61401397550
Fax 132328 0
Email 132328 0
tgraemescully@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All De-identified data regarding demographics and diagnostic tests
When will data be available (start and end dates)?
From time of publication to 7 years when data is destroyed as per ethics
Available to whom?
Case by case discretion at discretion of primary sponsor
Available for what types of analyses?
Meta-analyses or other justified reasons
How or where can data be obtained?
Contact the principal investigaton: tgraemescully@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21616Study protocol    387317-(Uploaded-04-04-2024-20-14-13)-Study-related document.docx
21617Informed consent form    387317-(Uploaded-04-04-2024-20-14-33)-Study-related document.docx



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.