Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

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

Study Overview

• Status: Completed
• Conditions: Cardiomyopathies; Conditioning; Heart Rate
• Intervention / Treatment: Other: novel atrial pacing approach; Other: sham pacing approach

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52240
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Denise Hodgson-Zingman
• Investigators: Principal Investigator: Denice Hodgson-Zingman, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 202202351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No