RecruitingNot applicable

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)

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
Not stated

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
Not stated
  • 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 whether the Barostim System is safe and helps adults with heart failure who still have symptoms despite standard treatment. It compares Barostim with usual care to see if it lowers deaths and serious heart failure problems.

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).

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

Eligibility

Who can join

  • Be age 18 or older.
  • Have heart failure symptoms during ordinary or lighter activity (NYHA class II or III).
  • Have a heart pumping measure called ejection fraction below 50%, tested within 6 months before consent.
  • Meet the study’s blood test rules for heart strain, or have a recent worsening heart failure event and meet blood test limits. Limits depend on body size; people taking Entresto must use the NT-proBNP test.
  • Be on the best standard heart failure medicines and devices you can tolerate for at least 4 weeks before consent and during screening. Most medicine dose changes are limited.
  • Walk 100 to 450 meters in 6 minutes, tested within 15 days after consent.
  • If you are female and could become pregnant, have a negative pregnancy test within 15 days after consent.
  • Be judged suitable for the study and implant surgery by the study team, and sign a consent form.

Who can't join

  • Have a condition or an existing device that makes Barostim unsafe to use.
  • Have advanced heart failure, repeated very high heart strain blood tests, or past or current IV drugs to help the heart pump. Also excluded: a past, current, or planned heart pump device; an organ or blood-related transplant; or evaluation for a heart transplant.
  • Have very poor kidney function, end-stage kidney disease, or past or current long-term dialysis.
  • Have repeated low blood pressure that causes symptoms, or a life expectancy under 1 year.
  • Have certain types of high blood pressure in the lungs; severe lung disease needing oxygen or long-term steroid pills; heart failure from a reversible cause; active cancer other than non-melanoma skin cancer; or harmful deposits in the heart muscle. Other serious health problems may also rule you out.
  • Within 3 months before consent, have had a heart attack, unstable chest pain, stroke or mini-stroke, cardiac arrest, a procedure to open heart arteries, or heart surgery or device procedures. Surgery planned within 45 days of the Barostim implant also rules you out.
  • Be active in another clinical trial without approval from the study sponsor’s research department.
  • Be unable or unwilling to follow medicine and follow-up rules, or unable to freely give informed consent, as judged by the study team.

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

Official eligibility criteria

Inclusion Criteria: 1. Age 18 years or above 2. NYHA Functional Class II or III heart failure symptoms at the time of screening 3. Left ventricular ejection fraction \< 50% within 6 months of consent 4. 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. 5. 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. 6. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent. 7. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent. 8. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon. 9. Have signed an informed consent form for participation in this trial. Exclusion Criteria: 1. Any contraindications to Barostim as noted in Instructions for Use. 2. An existing device which contraindicates Barostim specifically or unipolar therapy in general. 3. 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. 4. Serum estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73 m2 or has end-stage renal disease. 5. Recurring symptomatic hypotension. 6. Life expectancy less than one year. 7. 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. 8. 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 * Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements) 9. Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements. 10. Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department. 11. Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder. Participant is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Study sites (20)

AL

CA

FL

IL

IN

MA

MO

NE

OH

OK

SD

TN

TX

WI