Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Denise Hodgson-Zingman

Status: Completed

Conditions: Conditioning; Cardiomyopathies; Heart Rate

Treatments: Other: sham pacing approach; Other: novel atrial pacing approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05600725

202202351

Details and patient eligibility

About

This project utilizes a novel cardiac pacing approach hypothesized to initiate beneficial cardiac conditioning and remodeling over a period of time.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Pacing intervention

Experimental group

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.

Treatment:

Other: novel atrial pacing approach

Sham pacing

Sham Comparator group

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.

Treatment:

Other: sham pacing approach