Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Quality of life/symptom score
Study Overview
Brief Summary
This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Subjects will be unaware of their group assignment. Investigators delivering the intervention vs. sham will be aware. Analysts processing primary data (serum testing, echocardiographic dimensions, 6-min walk distance, CPEX) will not be aware of group assignments.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-Ischemic Cardiomyopathy
- •Ejection Fraction </= 35% despite at least 3 months stable standard medical management
- •New York Heart Association Class II-III symptoms
- •Dual chamber implantable cardioverter defibrillator in place or Biventricular ICD in place (over 3 months old)
- •Normal Atrioventricular conduction or Biventricular ICD
- •QRS < 120 msec (inherent conduction or paced with BiV ICD)
- •Exclusion criteria:
- •Age < 18 years
- •Inability to ambulate safely
- •Congenital or primary valve disease
- •Left Ventricular thrombus
- •Severe peripheral arterial disease
- •Admission for life-threatening condition (eg heart failure, stroke) in the past 3 months
- •Major surgery in the past 3 months or anticipated during the period of the trial
- •Paced or intrinsic QRS >120 msec
- •Life expectancy < 1 year
- •Hemodialysis
- •Hematocrit < 30%
- •Severe Chronic lung disease
- •Pregnancy
- •ICD battery longevity < 1 year
- •Unsuppressed atrial arrhythmias
- •Already participating in an exercise programusion Criteria
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Quality of life/symptom score
Time Frame: 4 weeks after start of the protocol
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
Secondary Outcomes
- six minute walk(at the time of enrollment, and at 4 weeks after start of the protocol)
- diastolic blood pressure(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- systolic blood pressure(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- MACE(4 weeks and 4 months after start of the protocol)
- Oxygen saturation(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
- cardiac output(every 5 minutes during intervention/sham in weeks 1-4 of the protocol)
Investigators
Denise Hodgson-Zingman
Professor
University of Iowa