Pacemaker Rate Adjustment for Cardiac Amyloidosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how adjusting pacemaker settings can assist individuals with cardiac amyloidosis, a condition where protein deposits stiffen the heart and reduce its effectiveness. Researchers aim to determine if increasing the pacemaker rate improves heart failure symptoms and exercise tolerance. The trial targets individuals who already have a pacemaker and a diagnosis of cardiac amyloidosis, involving a personalized pacing protocol. Participants must not have a dilated heart chamber, as confirmed by an ultrasound.
As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart health for many.
What prior data suggests that this pacemaker rate adjustment is safe for cardiac amyloidosis patients?
Research has shown that pacemakers are generally safe for people with cardiac amyloidosis, a condition where unusual proteins build up in the heart. Studies indicate that using pacemakers in these patients is common and usually well-tolerated. For instance, one study found that 3.9% of patients with cardiac amyloidosis who had pacemakers experienced some irregular heartbeats, but the devices helped manage these symptoms. Another study reported a low 1.8% rate of sudden death over two years in patients with pacemakers, suggesting that the risk of serious events is relatively low. Overall, adjusting pacemaker settings appears safe and can significantly improve heart function for many patients.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a personalized approach to managing cardiac amyloidosis with pacemakers. Unlike standard pacemaker settings, this method tailors the pacemaker rate to each patient's unique characteristics, such as their height and heart's pumping efficiency. This personalized pacing protocol could potentially improve heart function and patient outcomes more effectively than the one-size-fits-all settings currently used.
What evidence suggests that pacemaker rate adjustment is effective for cardiac amyloidosis?
Research has shown that increasing the pacemaker's rate can improve heart function in people with cardiac amyloidosis. In this trial, participants will receive a personalized pacing protocol based on their height and left ventricular ejection fraction. Studies have found that adjusting pacemaker settings can alleviate heart failure symptoms and make exercise easier. Evidence indicates that nearly all patients with cardiac amyloidosis will eventually require some form of pacing, underscoring the importance of pacemaker adjustments for heart health. While pacemakers alone may not completely resolve the issue, customizing the pacing can offer significant benefits.12467
Who Is on the Research Team?
Valmiki Maharaj
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for people with cardiac amyloidosis who already have a pacemaker. Participants should be able to safely undergo changes in their pacemaker settings and must not have other serious health issues that would make participation unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a personalized pacing protocol based on their height and left ventricular ejection fraction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pacemaker Rate
Trial Overview
The study tests whether increasing the heart rate setting on existing pacemakers can improve heart failure symptoms and exercise ability in patients with cardiac amyloidosis. It observes participants before and after this change.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
CA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Elevated Rate Pacing of Cardiac Amyloidosis
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome ...
Predictors and outcomes of pacemaker implantation in ...
Heart failure and cardiomyopathies. Original research. Predictors and outcomes of pacemaker implantation in patients with cardiac amyloidosis. Free. Loading.
Predictors and outcomes of pacemaker implantation in ...
We sought to investigate prevalence, incidence and prognostic implications of permanent pacemaker (PPM) implantation in patients with cardiac amyloidosis (CA)
Elevated Rate Pacing of Cardiac Amyloidosis
This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate ...
Management of conduction disease and arrhythmias in ...
Touboul et al. observed an 88% DCC acute success rate in 66 patients with cardiac amyloidosis [44], similar to that in the Euro Heart Survey ...
Incidence, predictors and outcomes associated with ...
Arrhythmias are poorly tolerated by patients with transthyretin cardiac amyloidosis (ATTR). The occurrence rate of pacemaker (PM) ...
Incidence and predictors of sudden death in patients with ...
Event rate at 2 years was 1.8% (0.72 events/100 person-years). PEA was the first rhythm in 4 cases (36%) while no information was available in ...
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