Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Enrolling by invitation · Not applicable

Conditions studied: Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III

In brief

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).

Key facts

Study ID

NCT07232030

Run by

CVRx, Inc.

People needed

2500

Starts

2026-04-24

Expected to finish

2033-01-01

Last updated by the study team

2026-07-29

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• Any contraindications to Barostim as noted in Instructions for Use.
• An existing device which contraindicates Barostim specifically or unipolar therapy in general.
• Advanced heart failure defined by any of the following:
• AHA/ACC Stage D heart failure.
• Two or more NT-proBNP results >5,000 pg/mL or BNP >1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.
• Current or prior continuous or intermittent intravenous positive inotrope therapy.
• Has received, is receiving, or scheduled to receive LVAD therapy.
• Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.
• Serum estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m2 or has end-stage renal disease.
• Recurring symptomatic hypotension.
• Life expectancy less than one year.
• An inappropriate trial candidate as evidenced by at least one of the following:
• Has received or is receiving chronic dialysis.
• Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.
• Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.
• Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
• Active malignancy with the exception of non-melanoma skin cancers.
• Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
• Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator.
• Any of the following within 3 months prior to consent:
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention (e.g. PTCA)
• Cerebral vascular accident or transient ischemic attack
• Cardiac arrest

Where it is running

• Cardiology Associates of Mobile — Mobile, Alabama, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• BayCare Health Systems — Tampa, Florida, United States
• North Central Heart — Sioux Falls, South Dakota, United States
• Erlanger Health — Chattanooga, Tennessee, United States
• CHRISTUS Trinity Mother Frances — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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