Back to resultsNovel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
Primary Purpose
Cardiomyopathies, Heart Rate, Conditioning
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
novel atrial pacing approach
sham pacing approach
Sponsored by
About this trial
This is an interventional treatment trial for Cardiomyopathies
Eligibility Criteria
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
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Pacing intervention
Sham pacing
Arm Description
A novel atrial pacing approach will be delivered using the subject's already implanted pacemaker, ICD or BiV/ICD while the subject is in a semi-recumbent position and while hemodynamic and symptom data is collected. This will be repeated once daily, 3d/wk over 4 weeks.
Subjects in this arm will be treated identically to the subjects in the pacing intervention arm but their already implanted pacemaker, ICD or BiV/ICD will have programming changes simulated but not actually implemented.
Outcomes
Primary Outcome Measures
Quality of life/symptom score
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)
Secondary Outcome Measures
systolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
diastolic blood pressure
systolic blood pressure (mmHg) as a continuous variable
Oxygen saturation
oxygen saturation by pulse oximeter (%) as a continuous variable
cardiac output
cardiac output (liters/minute) as measured by thoracic impedance and reported as a continuous variable
MACE
Major adverse cardiac events: composite of total death, MI, stroke, hospitalization due to heart failure, revascularization
six minute walk
distance ambulated in 6 minutes (meters)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05600725
Brief Title
Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
Official Title
Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Denise Hodgson-Zingman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathies, Heart Rate, Conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacing intervention
Arm Type
Experimental
Arm Description
A novel atrial pacing approach will be delivered using the subject's already implanted pacemaker, ICD or BiV/ICD while the subject is in a semi-recumbent position and while hemodynamic and symptom data is collected. This will be repeated once daily, 3d/wk over 4 weeks.
Arm Title
Sham pacing
Arm Type
Sham Comparator
Arm Description
Subjects in this arm will be treated identically to the subjects in the pacing intervention arm but their already implanted pacemaker, ICD or BiV/ICD will have programming changes simulated but not actually implemented.
Intervention Type
Other
Intervention Name(s)
novel atrial pacing approach
Intervention Description
See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.
Intervention Type
Other
Intervention Name(s)
sham pacing approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life/symptom score
Description
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
Secondary Outcome Measure Information:
Title
systolic blood pressure
Description
systolic blood pressure (mmHg) as a continuous variable
Time Frame
every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Title
diastolic blood pressure
Description
systolic blood pressure (mmHg) as a continuous variable
Time Frame
every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Title
Oxygen saturation
Description
oxygen saturation by pulse oximeter (%) as a continuous variable
Time Frame
every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Title
cardiac output
Description
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
Title
MACE
Description
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
Title
six minute walk
Description
distance ambulated in 6 minutes (meters)
Time Frame
at the time of enrollment, and at 4 weeks after start of the protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denice Hodgson-Zingman, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
12. IPD Sharing Statement
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Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
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