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OpenTrials
Completed

NCT Number: NCT05600725

Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Quality of life/symptom score

    Time frame: 4 weeks after start of the protocol

    Minnesota Living with Heart Failure Score (range 0-105, higher scores indicate worse quality of life)

Secondary outcomes

  1. systolic blood pressure

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

    systolic blood pressure (mmHg) as a continuous variable

  2. diastolic blood pressure

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

    systolic blood pressure (mmHg) as a continuous variable

  3. Oxygen saturation

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

    oxygen saturation by pulse oximeter (%) as a continuous variable

  4. cardiac output

    Time frame: 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

  5. MACE

    Time frame: 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

  6. six minute walk

    Time frame: at the time of enrollment, and at 4 weeks after start of the protocol

    distance ambulated in 6 minutes (meters)

Sponsors and collaborators

Lead sponsor

Denise Hodgson-Zingman

Other

Registry information

Official study title

Novel Pacing Modality to Initiate Favorable Cardiac Remodeling in Heart Disease

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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