Elevated Rate Pacing of Cardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
This study aims to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 cardiac amyloidosis patients with preexisting pacemakers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18 and older
Diagnosis of cardiac amyloidosis as indicated by the criteria set forth in guidelines such as in Kittleson et al: "2023 ACC Expert Consensus Decision Pathway on Comprehensive Multidisciplinary Care for the Patient With Cardiac Amyloidosis: A Report of the American College of Cardiology Solution Set Oversight Committee
Implanted Cardiac Pacemaker (+/- Defibrillator)
Pacemaker mode of AAI or DDD if in sinus rhythm, VVI acceptable if permanent atrial fibrillation
Disqualifiers
Paced QRS duration of >150 ms (indicator for pacing mediated dyssynchrony)
Dilated left ventricle
Trial design
Design model
Single group
Treatments tested in this trial
Pacemaker Rate
Other interventionCA clinic patients with pacemakers will receive a personalized pacing protocol individual to their height and left ventricular ejection fraction.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Elevated Pacemaker RateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Kansas City Cardiomyopathy Questionnaire Score
75-100 representing good to excellent health, and 0-24 representing very poor to poor health
Time frame
Month 42
Composite of any cardiovascular event
admission or urgent visit for heart failure and atrial fibrillation, myocardial infarction or stroke
Time frame
Month 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov