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Paced Heart Rate Acceleration for Cardiac Conditioning

A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether making the heart beat faster with an implanted device while a person rests can improve heart pumping, like exercise may do. It is for adults with a weak heart who take recommended medicines and already have an implanted defibrillator. The study compares pacing with a sham treatment, which does not give the tested pacing, 3 days a week for 6 weeks.

A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Sign a consent form and agree to follow study steps for the full study.
  • Have transportation to study visits.
  • Have a left heart pumping chamber that pumps out 40% or less of its blood per beat, despite at least 3 months of recommended medicines.
  • Have heart failure symptoms that limit ordinary activity or happen with less than ordinary activity (NYHA class II–III).
  • Have an implanted defibrillator for more than 3 months, with a wire in an upper heart chamber. A device that also paces both lower chambers is allowed.
  • Have a QRS time of 120 milliseconds or less—a measure of how fast an electrical signal moves through the lower heart chambers—with your own heartbeat or pacing of both lower chambers.

Who can't join

  • Be under 18, be pregnant, or be a prisoner or someone living in an institution.
  • Be unable to walk safely; have severe artery disease that limits movement; or have severe long-term lung disease that limits activity or requires oxygen.
  • Have heart valve disease present from birth or caused by a problem in the valve itself, ongoing abnormal rhythms in the upper heart chambers, or a blood clot in the left lower heart chamber.
  • Have been admitted to a hospital for a life-threatening condition in the past 3 months, or have had major surgery in that time or expect it during the study.
  • Need pacing of a lower heart chamber without pacing of both lower chambers, or have less than 1 year of battery life left in your defibrillator.
  • Be expected to live less than 1 year.
  • Receive hemodialysis, a treatment that uses a machine to clean the blood.
  • Have a hematocrit below 30%, meaning red blood cells make up less than 30% of your blood.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female sex * Age 18 years or greater * Available transportation for study visits * Left ventricular ejection fraction \< or = 40% despite at least 3 months guideline-directed medial therapy * NYHA class II-III heart failure symptoms * Atrial-lead inclusive implantable cardioverter defibrillator or biventricular defibrillator in place \> 3 months * Intrinsic or biventricular paced QRS duration of \<= 120 milliseconds Exclusion Criteria: * Age \< 18 years * Inability to ambulate safely * Congenital or primary valve disease * Ongoing (not suppressed) atrial arrhythmias * Left ventricular thrombus * Severe peripheral arterial disease that limits mobility * Hospital admission for life-threatening condition (e.g. heart failure, stroke) in the past 3 months * Major surgery in the past 3 months or anticipated during the period of study * Ventricular pacing indication in the absence of biventricular pacing * Life expectancy \< 1 year * Hemodialysis * Hematocrit \< 30% * Severe chronic lung disease that limits activity or requires oxygen * Pregnancy * Implantable cardioverter defibrillator battery longevity \< 1 year * Vulnerable populations such as prisoners and institutionalized individuals

Study sites (1)

IA