A New Pacing Approach for Cardiac Conditioning and Enhanced Cardioprotection

Plain English Summary

Paced Heart Rate Acceleration for Cardiac Conditioning is a Not Applicable clinical trial sponsored by Denice Hodgson-Zingman, MD studying Heart Failure, Systolic. This trial tests if a special pacing technique can mimic exercise to improve heart function in people with weakened hearts. It is for individuals with a specific type of heart failure (systolic) who already have a heart device (ICD or biventricular ICD). Participants will receive either the special pacing or a sham (fake) pacing for 6 weeks, with regular check-ups. Current treatments focus on medication and lifestyle changes; this study explores a new way to potentially enhance heart conditioning. The trial aims to enroll 52 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have a weakened left ventricle (ejection fraction <= 40%) despite medication, and have NYHA class II-III heart failure symptoms. You must have an existing implantable cardioverter defibrillator (ICD) or biventricular ICD for over 3 months and a QRS duration of <= 120 milliseconds. You cannot join if you have congenital or primary valve disease, ongoing atrial arrhythmias, a left ventricular thrombus, severe peripheral artery disease, or a life expectancy less than 1 year. Other reasons for exclusion include recent hospitalizations or major surgery, severe chronic lung disease, pregnancy, or a pacemaker battery with less than 1 year of life remaining. This trial is studying Heart Failure, Systolic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the main pumping chamber of the heart (left ventricle) is working, assessed by its ejection fraction, to see if the pacing improves its ability to pump blood. The specific primary outcome measures are: Change in left ventricular ejection fraction by echocardiogram (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to understand if mimicking exercise with heart pacing can improve heart function, potentially offering a new therapeutic approach for patients with heart failure and reduced ejection f This research targets Heart Failure, Systolic, where improved treatment options are needed.

Investor Insight

This trial investigates a novel, non-pharmacological intervention for a significant patient population, potentially offering a new device-based therapy for heart failure, which could represent a new m

Is This Trial Right for Me?

Ask your doctor if this trial is suitable for your specific heart condition and if the pacing intervention could benefit you. Understand that participation involves regular visits for check-ups and device programming over several months. Daily life may involve following the pacing schedule and attending all scheduled appointments for monitoring. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 52 participants

Interventions

• DEVICE: Exercise-similar cardiac pacing — Cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.
• DEVICE: Sham cardiac pacing — Simulated (rates selected using programmer but not initiated) cardiac pacing using subjects already-implanted cardioverter defibrillator to reproduced exercise heart rate envelope.

Primary Outcomes

• Change in left ventricular ejection fraction by echocardiogram (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)

Secondary Outcomes

• Quality of Life score on the Minnesota Living with Heart Failure questionnaire (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)
• Quality of Life score on the Kansas City Cardiomyopathy Questionnaire (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)
• 6-minute walk distance (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)
• Cardiopulmonary exercise test maximum oxygen consumption (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)
• Cardiopulmonary exercise test metabolic equivalents achieved (at baseline versus 2 weeks, 4 weeks, 6 weeks from start of intervention/sham and at 3 months and 12 months after completion of intervention vs. sham.)

Full 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

Trial Locations

• University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Frequently Asked Questions

Related Conditions

• Heart Failure, Systolic
• Cardiomyopathy
• Left Ventricular Dysfunction
• Heart Failure with Reduced Ejection Fraction (HFrEF)
• Arrhythmias
• Cardiac Pacing
• Implantable Cardioverter Defibrillator (ICD)
• Biventricular ICD
• Cardiac Conditioning
• Cardioprotection

More Heart Failure, Systolic Trials

View all Heart Failure, Systolic clinical trials