Assessment of CCM in HF With Higher Ejection Fraction (AIM HIGHer)
Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring HFpEF, Heart failure, CCM, CCM therapy, cardiac contractility modulation, symptomatic heart failure, left ventricular ejection fraction, LVEF, Optimizer, Optimizer Smart Mini, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent form;
- Male or non-pregnant female, 21 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤60% (as assessed by echo core lab);
- Heart failure hospitalization within 12 months prior to study consent OR Urgent heart failure visit requiring IV therapy during the 6 months prior to study consent;
- Elevated NT-proBNP levels, >200 pg/ml for subjects without atrial tachyarrhythmia (AT) or >600 pg/ml for subjects in AT OR Elevated BNP levels, >75 pg/ml for subjects without AT or >225 pg/ml for subjects in AT;
6) Subjects must be on a stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy.
Exclusion Criteria:
- Resting heart rate <50 or >110 bpm;
- Resting systolic blood pressure <100 or ≥160 mmHg;
- BMI greater than 40
- Any moderate or 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);
- 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 <20 ml/min/1.73m2;
- Participating in another investigational study;
- 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;
Sites / Locations
- Grandview Medical Group Research, LLCRecruiting
- The University of Alabama at BirminghamRecruiting
- CardioVascular Associates of MesaRecruiting
- Chan Heart Rhythm InstituteRecruiting
- Southwest Cardiovascular AssociatesRecruiting
- Banner Health- PhoenixRecruiting
- Arizona Heart RhythmRecruiting
- Cardiovascular Consultants, LtdRecruiting
- HonorHealthRecruiting
- Pima Heart and VascularRecruiting
- John Muir HealthRecruiting
- Northbay Heart and VascularRecruiting
- USC Keck School of MedicineRecruiting
- Cedars Sinai Medical CenterRecruiting
- Valley Clinical Trials- Foothill CardiologyRecruiting
- Valley Clinical Trials- NorthridgeRecruiting
- Sequoia HospitalRecruiting
- University of California Davis HealthRecruiting
- University of California, San FranciscoRecruiting
- Nuvance HealthRecruiting
- HCA Florida JFK HospitalRecruiting
- Nouvelle Clinical Research LLCRecruiting
- Holy Cross HospitalRecruiting
- Broward HealthRecruiting
- Memorial Healthcare SystemRecruiting
- Baptist Health South FloridaRecruiting
- NCA Research Institute - FloridaRecruiting
- AdventHealth OrlandoRecruiting
- Revival Clinical ResearchRecruiting
- Tallahassee Research InstituteRecruiting
- Cleveland Clinic Foundation - Florida Weston HospitalRecruiting
- Piedmont HealthcareRecruiting
- WellStar Health System, IncRecruiting
- Franciscan Health IndianapolisRecruiting
- Ascension Medical Group St. VincentRecruiting
- MercyOne Iowa HeartRecruiting
- University of Kansas Medical CenterRecruiting
- Kansas City Cardiac Arrhythmia Research LLCRecruiting
- Baptist Health LexingtonRecruiting
- University of Kentucky Research FoundationRecruiting
- Ochsner Clinic FoundationRecruiting
- Massachusetts General HospitalRecruiting
- Ascension St. JohnRecruiting
- Ascension Providence HospitalRecruiting
- Trinity health- Michigan HeartRecruiting
- Minneapolis Heart Institute at Abbott Northwestern HospitalRecruiting
- North Mississippi Medical CenterRecruiting
- St. Louis Heart and VascularRecruiting
- St. Luke's HospitalRecruiting
- St. Lukes Hospital Kansas City (Mid America Heart Institute)Recruiting
- Bryan HeartRecruiting
- University of Nebraska Medical CenterRecruiting
- Catholic Medical CenterRecruiting
- Our Lady of LourdesRecruiting
- Hackensack University Medical CenterRecruiting
- Jersey Shore University Medical CenterRecruiting
- Cooper Hospital- Cardiovascular Associates of Delaware ValleyRecruiting
- Atlantic Health System- Morristown Medical CenterRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Weill Cornell MedicineRecruiting
- Sanger Heart and VascularRecruiting
- TriHealth BethesdaRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Wexner Medical CenterRecruiting
- OhioHealth Research InstituteRecruiting
- Mercy Health- St. Vincent Medical Center LLCRecruiting
- Oklahoma Heart InstituteRecruiting
- Providence Heart & VascularRecruiting
- Bryn Mawr Medical Specialists AssociationRecruiting
- UPMC Pinnacle HarrisburgRecruiting
- Penn State Hershey Medical CityRecruiting
- Lancaster General Hospital
- Penn Presbyterian Medical CenterRecruiting
- Hospital of the University of PennsylvaniaRecruiting
- Temple University HospitalRecruiting
- Allegheny General HospitalRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Tower Health Reading HospitalRecruiting
- Prisma Health UpstateRecruiting
- The Stern Cardiovascular FoundationRecruiting
- Texas Cardiac Arrhythmia Research FoundationRecruiting
- Ascension SetonRecruiting
- Austin HeartRecruiting
- Baylor Scott and White Research InstituteRecruiting
- HCA Medical City DallasRecruiting
- Baylor Scott White- All Saints- Fort WorthRecruiting
- Medical City Fort Worth HospitalRecruiting
- Baylor College of MedicineRecruiting
- Houston MethodistRecruiting
- Memorial Hermann Texas Medical CenterRecruiting
- Heart Rhythm SpecialistsRecruiting
- Baylor Scott and White- The Heart Hospital- PlanoRecruiting
- Baylor Scott and White Research Institute - Round RockRecruiting
- Methodist HospitalRecruiting
- Peace HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
CCM Group (CCM ON)
Sham Group (CCM OFF)
CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.
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.