Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

NCT05600725 | Completed DMC

• 1 other identifier: 202202351
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiomyopathies; Heart Rate; Conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• systolic blood pressure

  every 5 minutes during intervention/sham in weeks 1-4 of the protocol

• diastolic blood pressure

  every 5 minutes during intervention/sham in weeks 1-4 of the protocol

• Oxygen saturation

  every 5 minutes during intervention/sham in weeks 1-4 of the protocol

• cardiac output

  every 5 minutes during intervention/sham in weeks 1-4 of the protocol

• MACE

  4 weeks and 4 months after start of the protocol

Study Arms (2)

Pacing intervention

EXPERIMENTAL

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

Sham pacing

SHAM COMPARATOR

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

Interventions

novel atrial pacing approach OTHER

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

Pacing intervention

sham pacing approach 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.

Sham pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Denise Hodgson-Zingman: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52240, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Denice Hodgson-Zingman, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be unaware of their group assignment. Investigators delivering the intervention vs. sham will be aware. Analysts processing primary data (serum testing, echocardiographic dimensions, 6-min walk distance, CPEX) will not be aware of group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomized in a single-blinded fashion to intervention vs. sham treatment

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: October 31, 2022
• Study Start: November 2, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

US (1)