None listed
Conditions
Brief summary
Patients with a restrictive cardiomyopathy, such as in cardiac amyloidosis, have poor heart function due to the increased stiffness of their heart. These patients usually compensate by increasing their heart rate. In patients with pacemakers, the ability to increase their own heart rate naturally is usually impaired. This trial is aiming to assess if using the pacemaker to increase the patient's heart rate results in better heart function and quality of life in patients with cardiac amyloidosis who have pacemakers. It is hypothesized that patients with an accelerated pacemaker rate will have an improvement in the function of their heart and quality of life compared to those with a lower pacemaker rate.
Interventions
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
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.
Sponsors
Alfred Health Cardiology Department
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed