Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000408482
Ethics application status
Approved
Date submitted
15/04/2025
Date registered
5/05/2025
Date last updated
5/05/2025
Date data sharing statement initially provided
5/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimal heart rates in patients with Cardiac Amyloidosis and pacemakers.
Scientific title
Assess the quality of life for cardiac pacing augmented myocardial dynamics in patients with transthyretin cardiac amyloidosis
Secondary ID [1] 314215 0
None
Universal Trial Number (UTN)
Trial acronym
CAPACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyloidosis 337117 0
Condition category
Condition code
Cardiovascular 333537 333537 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 333538 333538 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective pilot study of cardiac pacing augmented myocardial dynamics in patients with transthyretin cardiac amyloidosis. The study includes enrolment then two site study visits and a final phone call at 1 year. During the first visit a patient will undergo clinical assessment with physical examination, quality of life survey, 6 minute walk test, electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance imaging (CMR) at three different pacing rates, assessing the cardiac response to each heart rate. Cardiac device pacing rate will then be set to the individually optimised pacing rates as per CMR for one month.
The second visit at one month will include brief physical examination, quality of life survey, 6 minute walk test, electrocardiogram (ECG), echocardiogram. Cardiac devices will be interrogated to confirm the heart rate paced during the prior intervention period and reprogrammed to their original settings.
Patients will receive a brief follow up phone call at 1 year.
Intervention code [1] 330824 0
Treatment: Devices
Comparator / control treatment
Each participant is their own control
Control group
Active

Outcomes
Primary outcome [1] 341118 0
To assess the change in quality-of-life score with individually optimized CMR pacing rates in patients with cardiac amyloidosis from baseline to one month.
Timepoint [1] 341118 0
One month post commencement of intervention
Secondary outcome [1] 446339 0
To assess the change in cardiac output by CMR at different cardiac implantable electronic device pacing rates in patients with cardiac amyloidosis.
Timepoint [1] 446339 0
At time of acquisition of imaging (First study visit)

Eligibility
Key inclusion criteria
• People who meet diagnostic criteria for transthyretin cardiac amyloidosis
• Cardiac implantable electronic device (pacemakers or defibrillator) which is MRI compatible.
• Underlying native heart rate of 60 beats per minute or less.
• Willingness to give written informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with any contraindications for CMR imaging including:
o Patients with previous allergy to gadolinium.
o Patients with a history of significant renal impairment (eGFR< 30ml/min/1.73m2).
o Patients who are medically unstable.
o Patients with claustrophobia.
o Cardiac pacemakers or implantable cardioverter defibrillator not deemed to be MRI compatible.
o Pregnancy or lactating.
o Orbital foreign bodies from metal injury to the eye.
o Intracranial metal clips.
o Non-MRI compatible stapes implants.
o Programmable Hydrocephalus Shunts.
o Large metal implants.
• Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Study design
Purpose of the study
Treatment
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
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
19/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27783 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 43972 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 318732 0
Hospital
Name [1] 318732 0
St Vincent's Hospital Sydney
Country [1] 318732 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
Country
Australia
Secondary sponsor category [1] 321338 0
None
Name [1] 321338 0
Address [1] 321338 0
Country [1] 321338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317345 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317345 0
Ethics committee country [1] 317345 0
Australia
Date submitted for ethics approval [1] 317345 0
07/11/2024
Approval date [1] 317345 0
17/12/2024
Ethics approval number [1] 317345 0
2024/ETH02406

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140750 0
Prof Andrew Jabbour
Address 140750 0
St Vincent's Hospital Sydney, 390 Victoria St, Darlinghurst, 2010, NSW
Country 140750 0
Australia
Phone 140750 0
+61 28038 1080
Fax 140750 0
Email 140750 0
[email protected]
Contact person for public queries
Name 140751 0
Dr Natasha Gorrie
Address 140751 0
St Vincent's Hospital Sydney, 390 Victoria St, Darlinghurst, 2010, NSW
Country 140751 0
Australia
Phone 140751 0
+61 423173865
Fax 140751 0
Email 140751 0
[email protected]
Contact person for scientific queries
Name 140752 0
Dr Natasha Gorrie
Address 140752 0
St Vincent's Hospital Sydney, 390 Victoria St, Darlinghurst, 2010, NSW
Country 140752 0
Australia
Phone 140752 0
+61 423173865
Fax 140752 0
Email 140752 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.