Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Sponsor

Denise Hodgson-Zingman (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05600725

Collaborator

(none)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathies Heart Rate Conditioning	Other: novel atrial pacing approach Other: sham pacing approach	N/A

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

Anticipated Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatmentSubjects will be randomized in a single-blinded fashion to intervention vs. sham 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.

Primary Purpose:

Treatment

Official Title:

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pacing intervention 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.	Other: novel atrial pacing approach See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.
Sham Comparator: Sham pacing 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.	Other: sham pacing approach 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.

Arm

Intervention/Treatment

Experimental: Pacing intervention

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.

Other: novel atrial pacing approach

See US Patent #10987516. An atrial pacing method that preserves atrioventricular and interventricular synchrony to reproduce an exercise-typical envelope of heart rate.

Sham Comparator: Sham pacing

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.

Other: sham pacing approach

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.

Outcome Measures

Primary Outcome Measures

Quality of life/symptom score [4 weeks after start of the protocol]
Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)

Secondary Outcome Measures

systolic blood pressure [every 5 minutes during intervention/sham in weeks 1-4 of the protocol]
systolic blood pressure (mmHg) as a continuous variable
diastolic blood pressure [every 5 minutes during intervention/sham in weeks 1-4 of the protocol]
systolic blood pressure (mmHg) as a continuous variable
Oxygen saturation [every 5 minutes during intervention/sham in weeks 1-4 of the protocol]
oxygen saturation by pulse oximeter (%) as a continuous variable
cardiac output [every 5 minutes during intervention/sham in weeks 1-4 of the protocol]
cardiac output (liters/minute) as measured by thoracic impedance and reported as a continuous variable
MACE [4 weeks and 4 months after start of the protocol]
Major adverse cardiac events: composite of total death, MI, stroke, hospitalization due to heart failure, revascularization
six minute walk [at the time of enrollment, and at 4 weeks after start of the protocol]
distance ambulated in 6 minutes (meters)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52240

Sponsors and Collaborators

Denise Hodgson-Zingman

Investigators

Principal Investigator: Denice Hodgson-Zingman, MD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Denise Hodgson-Zingman, Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT05600725

Other Study ID Numbers:

202202351

First Posted:

Oct 31, 2022

Last Update Posted:

Nov 22, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiomyopathies

Study Results

No Results Posted as of Nov 22, 2022