Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

NCT ID: NCT05600725

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-02-28

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.

Conditions

Cardiomyopathies; Heart Rate; Conditioning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

novel atrial pacing approach

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

sham pacing approach

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Denise Hodgson-Zingman

OTHER

Sponsor Role: lead

Responsible Party

Denise Hodgson-Zingman

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Denice Hodgson-Zingman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202202351

Identifier Type: -

Identifier Source: org_study_id