What side effects are associated with this type of intervention?

Common treatments for heart failure that enhance cardiac muscle contractions without significantly increasing oxygen consumption include Cardiac Contractility Modulation (CCM) therapy, beta-blockers, and certain inotropic agents. CCM therapy is generally well-tolerated but can cause side effects such as local infection at the device implantation site, arrhythmias, and lead dislodgement. Beta-blockers, which reduce the heart's workload and improve its efficiency, can cause fatigue, dizziness, and bradycardia. Inotropic agents like digoxin can improve heart contractility but may lead to side effects such as nausea, vomiting, arrhythmias, and visual disturbances.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that aim to improve cardiac function. While specific details on treatments exactly like Cardiac Contractility Modulation (CCM) therapy are not provided, traditional heart failure treatments include medications such as beta-blockers, ACE inhibitors, and ARBs, which help manage symptoms and improve heart function. Additionally, devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices have been approved to support heart function. These treatments collectively aim to enhance the strength and efficiency of cardiac muscle contractions, similar to the goals of CCM therapy.

What other types of research exist?

Promising novel alternatives to CCM therapy for heart failure patients include: 1) SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin) which have shown benefits in heart failure with reduced and preserved ejection fraction, 2) Vericiguat, a soluble guanylate cyclase stimulator that improves outcomes in heart failure patients with reduced ejection fraction, and 3) Omecamtiv mecarbil, a cardiac myosin activator that enhances cardiac contractility without increasing myocardial oxygen consumption.

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Cardiac Contractility Modulation

CCM Therapy for Heart Failure (AIM HIGHer Trial)

N/A

Recruiting

Led By Javed Butler, MD, MPH, MBA

Research Sponsored by Impulse Dynamics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or non-pregnant female, 21 years or older;

Diagnosed with symptomatic heart failure;

Must not have

Any severe valvular stenotic disease or any severe valvular regurgitation

Complex congenital heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Summary

This trial tests a device that helps the heart pump better in patients with moderate heart failure. It targets those whose heart's pumping ability is moderately reduced. The device works by giving the heart small electrical boosts. Several new devices for the treatment of heart failure patients have been introduced and are increasingly used in medical practice or are under evaluation.

Who is the study for?

Adults diagnosed with symptomatic heart failure, who have been hospitalized for it or needed urgent IV therapy in the past year, and have a left ventricular ejection fraction (LVEF) between 40% and 60%. They must be on stable diuretic treatment. Exclusions include pregnancy plans during the study, certain heart rates, complex heart conditions, inability to walk specific distances, recent acute heart issues or procedures.

What is being tested?

The AIM HIGHer trial is testing the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy using the OPTIMIZER™ Smart Mini System in patients with moderate levels of heart failure (LVEF ≥40% ≤60%).

What are the potential side effects?

While not specified here, CCM therapy side effects may include discomfort at implant site, infection risk from surgery to place device, potential changes in heartbeat rhythm or interaction with other devices like pacemakers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man or a non-pregnant woman aged 21 or older.

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I have been diagnosed with heart failure that causes symptoms.

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I have been diagnosed with heart failure that causes symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart valve disease.

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I was born with a complex heart condition.

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I can't walk 100 meters but can walk more than 450 meters in a 6-minute walk test.

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My heart-related quality of life score is above 85.

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I have a type of heart disease that thickens, stiffens, or inflames my heart muscle.

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I have not had unstable chest pain in the last 30 days.

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I was treated for severe heart failure with IV or ultrafiltration in the last 30 days.

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I am on permanent dialysis or my kidney function is very low.

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I am currently receiving or have received cancer treatment in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.

Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).

Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CCM Group (CCM ON)Experimental Treatment1 Intervention

CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.

Group II: Sham Group (CCM OFF)Placebo Group1 Intervention

CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cardiac Contractility Modulation (CCM) therapy enhances the strength of cardiac muscle contractions without increasing oxygen consumption, which is crucial for improving cardiac output and efficiency in heart failure patients. Other common treatments include beta-blockers, which reduce heart rate and myocardial oxygen demand; ACE inhibitors and ARBs, which lower blood pressure and reduce strain on the heart; and diuretics, which decrease fluid overload and reduce symptoms of congestion. These therapies collectively aim to improve heart function, reduce symptoms, and enhance quality of life for heart failure patients.