RecruitingNot applicable

Assessment of CCM in HF With Higher Ejection Fraction

Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

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 and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

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

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • 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 how safe and effective Cardiac Contractility Modulation (CCM) therapy is for heart failure. It is for adults with heart failure symptoms whose left heart chamber pumps out 40% to 70% of its blood with each beat.

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%.

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

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be age 18 or older and not pregnant.
  • Have heart failure that causes symptoms.
  • Have a left ventricular ejection fraction (LVEF) of 40% to 70%, measured by a heart ultrasound. This is the share of blood pumped out with each beat.
  • Have had a heart failure hospital stay in the past 12 months or an urgent heart failure visit needing medicine through a vein in the past 6 months. Otherwise, a blood marker of heart strain must meet a required level adjusted for body size.
  • Take a scheduled loop diuretic (water pill) by mouth for at least 30 days before joining, unless you have a documented allergy or cannot tolerate it. The dose must not have more than doubled or dropped by more than half during that time; one 24-hour pause is allowed.
  • Instead of scheduled water pills, you may take an SGLT2 inhibitor medicine if the study doctor gives you a plan to take water pills as needed for symptoms or weight gain.

Who can't join

  • Resting heart rate below 50 or above 110 beats per minute; top blood pressure number below 100 or at least 160; or body mass index (BMI, a measure of weight for height) above 46.
  • Severely narrowed or leaky heart valves; a mechanical tricuspid valve; a complex heart problem present at birth; or certain heart muscle diseases involving thickening, buildup, stiffness, or inflammation.
  • Another condition greatly limits exercise or causes shortness of breath; you walk less than 100 or more than 450 meters in 6 minutes; or your KCCQ CCS heart failure health survey score is above 85.
  • New or worsening heart-related chest pain in the past 30 days; worsening heart failure needing treatment through a vein or blood filtering to remove fluid in the past 30 days; or a heart attack in the past 90 days.
  • Heart surgery or a catheter-based heart procedure is planned; heart surgery occurred in the past 90 days or a catheter-based procedure in the past 30 days; or you have had a heart transplant or heart pump device.
  • You receive cardiac resynchronization therapy (CRT), which helps the heart's chambers beat together. An exception applies if it was implanted more than a year ago and you still have heart failure classed as NYHA III or higher, meaning marked limits on activity or worse.
  • You plan to become pregnant; need permanent dialysis or have a kidney filtering rate below 15; are receiving chemotherapy or radiation for cancer; or had chemotherapy in the past 2 years.
  • You are in another drug or device study that could affect these results; are expected to live less than 18 months; or the study doctor believes you cannot follow the study plan.

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

Official eligibility criteria

Inclusion Criteria: 1. Signed and dated informed consent form; 2. Male or non-pregnant female, 18 years or older; 3. Diagnosed with symptomatic heart failure; 4. LVEF ≥40 and ≤70% (as assessed by site echo); 5. 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) 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. Exclusion Criteria: 1. Resting ventricular rate \<50 or \>110 bpm; 2. Resting systolic blood pressure \<100 or ≥160 mmHg; 3. BMI greater than 46 4. Any severe valvular stenotic disease or any severe valvular regurgitation; 5. Mechanical tricuspid valve; 6. Complex congenital heart disease; 7. 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; 8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT; 9. A KCCQ CCS score higher than 85; 10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy; 11. Unstable angina pectoris within 30 days prior to study consent; 12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting; 13. 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. 14. 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; 15. Myocardial infarction within 90 days prior to study consent; 16. Prior heart transplant or ventricular assist device; 17. Planning to become pregnant during the study; 18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2; 19. Participating in another investigational drug or device study that may interfere with the interpretation of study data; 20. 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; 21. Expected lifespan of less than 18 months from time of study consent; 22. Unable to follow through study protocol for any reasons in the investigator's judgement.

Study sites (105)

AL

AZ

CA

CT

FL

GA

IA

IN

KS

KY

LA

MA

MI

MN

MO

MS

NC

NE

NH

NJ

NY

OH

OK

OR

PA

SC

SD

TN

TX

VA

WA