Assessment of CCM in HF With Higher Ejection Fraction

Inclusion Criteria:

Signed and dated informed consent form;
Male or non-pregnant female, 18 years or older;
Diagnosed with symptomatic heart failure;
LVEF ≥40 and ≤60% (as assessed by echo core lab);
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, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) 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 B in Section 9.2.6)
Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance.

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:

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);
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;