Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000386437p
Ethics application status
Submitted, not yet approved
Date submitted
29/03/2025
Date registered
30/04/2025
Date last updated
30/04/2025
Date data sharing statement initially provided
30/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Moderately accelerated pacing in patients with cardiac amyloidosis
Scientific title
Evaluating the effect of moderately accelerated pacing on cardiac output in patients with cardiac amyloidosis
Secondary ID [1] 314245 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac amyloidosis 336851 0
Condition category
Condition code
Cardiovascular 333328 333328 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with cardiac amyloidosis and preserved ejection fraction on echocardiogram with a pacemaker in situ will be included.

Each patient would then be randomly assigned to different pacemaker settings in a crossover design. Patients would either be randomized to continuation of standard of care (i.e. no change in their pacemaker settings) or to accelerated physiologic pacing where their baseline pacemaker rate would be changed based on the myPACE protocol. The personalised heart rate would be calculated as personalized heart rate [bpm] = (Height [cm] x -0.37) + 135) x v (ejection fraction [%]/50). The pacemaker will be programmed by the pacemaker technician.

The first intervention period would be for 4 weeks following randomisation. Patients would then return and crossover to the opposite arm (i.e. patients with standard pacemaker settings would be swapped to the accelerated settings and those with accelerated settings would be swapped to standard pacemaker settings). There is no washout period between the first intervention period and the second intervention period. This second intervention period would last 4 weeks. The pacemaker settings will be checked prior to re-programming of settings at each follow up point to monitor adherence to the the intervention.
Intervention code [1] 330654 0
Treatment: Devices
Comparator / control treatment
As the design is a cross over trial, patients will serve as their own control comparator. Patients will either be randomised to the accelerated pacing arm or for their pacemaker settings to remain unchanged for the first 4 weeks. After 4 weeks, the patients with baseline pacemaker settings will be changed to accelerated pacing and those with accelerated pacing will have their pacemaker returned to baseline. This process will be blinded to the patient.
Control group
Active

Outcomes
Primary outcome [1] 340899 0
Change in cardiac output
Timepoint [1] 340899 0
At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2). This outcome will not be measured at baseline.
Secondary outcome [1] 445383 0
Change in pulmonary capillary wedge pressure
Timepoint [1] 445383 0
At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2). This outcome will not be measured at baseline.
Secondary outcome [2] 445384 0
Change in quality of life
Timepoint [2] 445384 0
At baseline (i.e. time of randomization). At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2).
Secondary outcome [3] 445385 0
Change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels
Timepoint [3] 445385 0
At baseline (i.e. time of randomization). At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2).
Secondary outcome [4] 445386 0
Change in exercise capacity
Timepoint [4] 445386 0
At baseline (i.e. time of randomization). At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2).
Secondary outcome [5] 445387 0
Atrial fibrillation (burden)
Timepoint [5] 445387 0
At baseline (i.e. time of randomization). At 4 weeks following randomization (end of intervention period 1) . At 8 weeks following randomization (end of intervention period 2).

Eligibility
Key inclusion criteria
1. Age 18 years or older
2. Echocardiogram or cardiac MRI within the past 12 months demonstrating left ventricular ejection fraction greater than or equal to 50%.
3. Diagnosis of either transthyretin or light chain cardiac amyloidosis.
4. Dual chamber pacemaker with a lower heart rate limit of less than or equal 60 bpm.
5. Heart failure symptoms with New York Heart Association (NYHA) class I-III
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Left ventricular ejection fraction < 50%.
2. NYHA class IV.
3. Chronic kidney disease stage IV/V or dialysis dependent (eGFR < 30).
4. Pacemaker with less than 6 months of device battery life.
5. Life expectancy < 12 months.
6. More than moderate valvular disease.
7. Aortic valve replacement within 1 year.
8. Predominantly ventricular pacing unless pacemaker dependent or device is a cardiac resynchronization device/physiologic pacing device (i.e. deep septal pacing device).
9. Pacing QRS duration of > 150 ms.
10. Enrollment in another trial that could confound results of this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involvescontacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random block sizes of 2 and 4 created using Stata statistical software by an investigator with no clinical involvement in the trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
33
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27672 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 27673 0
The Alfred - Melbourne
Recruitment hospital [3] 27674 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 43847 0
3128 - Box Hill
Recruitment postcode(s) [2] 43848 0
3004 - Melbourne
Recruitment postcode(s) [3] 43849 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 318586 0
Hospital
Name [1] 318586 0
Alfred Health
Country [1] 318586 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health Cardiology Department
Address
Country
Australia
Secondary sponsor category [1] 320982 0
None
Name [1] 320982 0
Address [1] 320982 0
Country [1] 320982 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317184 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317184 0
Ethics committee country [1] 317184 0
Australia
Date submitted for ethics approval [1] 317184 0
26/03/2025
Approval date [1] 317184 0
Ethics approval number [1] 317184 0

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

Contacts
Principal investigator
Name 140278 0
A/Prof James Hare
Address 140278 0
Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004
Country 140278 0
Australia
Phone 140278 0
+61 3 9076 5754
Fax 140278 0
Email 140278 0
[email protected]
Contact person for public queries
Name 140279 0
Timothy Scully
Address 140279 0
Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004
Country 140279 0
Australia
Phone 140279 0
+61401397550
Fax 140279 0
Email 140279 0
[email protected]
Contact person for scientific queries
Name 140280 0
Timothy Scully
Address 140280 0
Alfred Hospital, 55 Commercial Rd, Melbourne VIC 3004
Country 140280 0
Australia
Phone 140280 0
+61401397550
Fax 140280 0
Email 140280 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.