Assessment of CCM in HF With Higher Ejection Fraction

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction, Diastolic Heart Failure

In brief

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.

Key facts

Study ID

NCT05064709

Run by

Impulse Dynamics

People needed

1500

Starts

2022-02-03

Expected to finish

2029-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated informed consent form;
• Male or non-pregnant female, 18 years or older;
• Diagnosed with symptomatic heart failure;
• LVEF ≥40 and ≤70% (as assessed by site echo);
• A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
• Subjects must meet one of the following conditions:
• Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.
• Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.

You may not qualify if…

• Resting ventricular rate <50 or >110 bpm;
• Resting systolic blood pressure <100 or ≥160 mmHg;
• BMI greater than 46
• Any severe valvular stenotic disease or any severe valvular regurgitation;
• Mechanical tricuspid valve;
• Complex congenital heart disease;
• Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
• Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
• A KCCQ CCS score higher than 85;
• Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
• Unstable angina pectoris within 30 days prior to study consent;
• Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
• Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.
• Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
• Myocardial infarction within 90 days prior to study consent;
• Prior heart transplant or ventricular assist device;
• Planning to become pregnant during the study;
• Dialysis (permanent) or GFR <15 ml/min/1.73m2;
• Participating in another investigational drug or device study that may interfere with the interpretation of study data;
• Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
• Expected lifespan of less than 18 months from time of study consent;
• Unable to follow through study protocol for any reasons in the investigator's judgement.

Where it is running

• Cleveland Clinic Foundation - Florida Weston Hospital — Weston, Florida, United States (enrolling)
• Ascension Medical Group St. Vincent — Indianapolis, Indiana, United States (enrolling)
• CardioVascular Associates of Mesa — Mesa, Arizona, United States (enrolling)
• Revival Clinical Research — Orlando, Florida, United States (enrolling)
• Grandview Medical Group Research, LLC — Birmingham, Alabama, United States (enrolling)
• Chan Heart Rhythm Institute — Mesa, Arizona, United States (enrolling)
• Southwest Cardiovascular Associates — Mesa, Arizona, United States (enrolling)
• John Muir Health — Concord, California, United States (enrolling)
• University of California San Diego — La Jolla, California, United States (enrolling)
• Arizona Heart Rhythm — Phoenix, Arizona, United States (enrolling)
• Cardiovascular Consultants, Ltd — Phoenix, Arizona, United States (enrolling)
• Valley Clinical Trials- Northridge — Northridge, California, United States (enrolling)
• Sequoia Hospital — Redwood City, California, United States (enrolling)
• HonorHealth — Scottsdale, Arizona, United States (enrolling)
• Pima Heart and Vascular — Tuscon, Arizona, United States (enrolling)
• Nuvance Health - Danbury Hospital — Danbury, Connecticut, United States (enrolling)
• Hartford Healthcare — Hartford, Connecticut, United States (enrolling)
• HCA Florida JFK Hospital — Atlantis, Florida, United States (enrolling)
• Nouvelle Clinical Research LLC — Cutler Bay, Florida, United States (enrolling)
• Broward Health — Fort Lauderdale, Florida, United States (enrolling)
• USC Keck School of Medicine — Los Angeles, California, United States (enrolling)
• Baptist Health South Florida — Miami, Florida, United States (enrolling)
• Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.