Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

Cardiomyopathies Clinical Trial

Official title:

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600725
• Other study ID #: 202202351
• Status: Completed
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Conditioning
• Heart Rate

Intervention

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 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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Denise Hodgson-Zingman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	systolic blood pressure	systolic blood pressure (mmHg) as a continuous variable	every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Secondary	diastolic blood pressure	systolic blood pressure (mmHg) as a continuous variable	every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Secondary	Oxygen saturation	oxygen saturation by pulse oximeter (%) as a continuous variable	every 5 minutes during intervention/sham in weeks 1-4 of the protocol
Secondary	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
Secondary	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
Secondary	six minute walk	distance ambulated in 6 minutes (meters)	at the time of enrollment, and at 4 weeks after start of the protocol