Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Not Applicable

Completed

• Conditions: Cardiomyopathies; Heart Rate; Conditioning
• Interventions: Other: sham pacing approach; Other: novel atrial pacing approach

• Registration Number: NCT05600725
• Lead Sponsor: Denise Hodgson-Zingman

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 Timeline

• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-31
• Study Start: 2022-11-02
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-13
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham pacing	sham pacing approach	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.
Pacing intervention	novel atrial pacing approach	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
six minute walk	at the time of enrollment, and at 4 weeks after start of the protocol	distance ambulated in 6 minutes (meters)
diastolic blood pressure	every 5 minutes during intervention/sham in weeks 1-4 of the protocol	systolic blood pressure (mmHg) as a continuous variable
systolic blood pressure	every 5 minutes during intervention/sham in weeks 1-4 of the protocol	systolic blood pressure (mmHg) 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
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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States