This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.
The project studies subjects with non-ischemic cardiomyopathy who have a pacing device already implanted. Subjects randomized to the pacing intervention versus a sham intervention will be compared for various symptomatic, functional and other outcomes. Each subject will undergo baseline quality of life/symptom questionnaires and clinical testing for cardiac functional/structural effects and exercise tolerance, then the intervention vs. sham (subjects blinded to their category), followed by repeat questionnaires and clinical testing. Medical record review will be undertaken to establish demographic variables, baseline and follow up testing results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.
A pacemaker/ICD interrogator/programmer will be used to simulate changes in pacing rate over the same time period as the intervention group but the programming changes will not actually be implemented and not change in paced heart rate will occur.
University of Iowa
Iowa City, Iowa, United States
Quality of life/symptom score
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
Time frame: 4 weeks after start of the protocol
systolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
diastolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Oxygen saturation
oxygen saturation by pulse oximeter (%) as a continuous variable
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
cardiac output
cardiac output (liters/minute) as measured by thoracic impedance and reported as a continuous variable
Time frame: every 5 minutes during intervention/sham in weeks 1-4 of the protocol
MACE
Major adverse cardiac events: composite of total death, MI, stroke, hospitalization due to heart failure, revascularization
Time frame: 4 weeks and 4 months after start of the protocol
six minute walk
distance ambulated in 6 minutes (meters)
Time frame: at the time of enrollment, and at 4 weeks after start of the protocol
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