Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)
The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \< 50% and NT-proBNP \< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).
• Age 18 years or above
• NYHA Functional Class II or III heart failure symptoms at the time of screening
• Left ventricular ejection fraction \< 50% within 6 months of consent
• Heart failure accompanied by either:
‣ Screening local lab NT-proBNP ≥ 400 AND \< 5,000 pg/mL or a BNP ≥100 AND \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR
⁃ A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \< 5,000 pg/mL or BNP \< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting.
• Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg/m2.
• On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA/ACC guidelines, Germany follows DGK/ESC guidelines) for the treatment of heart failure, when appropriate, throughout screening/baseline evaluation and for at least 4 weeks prior to consent:
‣ No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.
⁃ Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.
⁃ Unrestricted changes in oral diuretics are allowed.
⁃ For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.
• Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.
• If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.
• Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.
• Have signed an informed consent form for participation in this trial.