Heart FailureBENEFIT-HFNCT07232030
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
A study testing Barostim System in people with Heart Failure and Heart Failure NYHA Class II, run by CVRx, Inc. at 20 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III
- What is being tested?
- Barostim System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 20 sitesUnited States
- Study dates
- 24 Apr 2026to Jan 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
- Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements)
- Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements.
- Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department.
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Michael S. Kiernan, MD, 617-636-5912, Fatima.Sow@tuftsmedicine.org
Michael S. Kiernan, MD
- Recruiting
Erlanger Health
Chattanooga, Tennessee, 37403
Lorraine Christensen, 423-778-3902, Lorraine.Christensen@erlanger.org
Patrick Stevens, MD
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
The Lindner Research Center at The Christ Hospital, 513-585-1777, katy.fischesser@thechristhospital.com
- Recruiting
BayCare Health System
Clearwater, Florida, 33756
Delia Johnson, RN, 727-462-3578, delia.johnson@baycare.org
Leslie Miller, MD
- Recruiting
Stern Cardiovascular Center
Germantown, Tennessee, 38138
Research Manager, 901-271-1000, rschreferral@sterncardio.com
Frank McGrew, MD
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46260
Ashwin Ravichandran, MD, 317-338-8042, morgan.arnold@ascension.org
Ashwin Ravichandran, MD
- Recruiting
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Vanessa Hernandez, 904-493-3333 ext. 1019, vhernandez@firstcoastcardio.com
Sumant Lamba, MD
- Not yet recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Marissa Beidelschies, 816-932-5634, Marissa.beidelschies@bjc.org
Timothy Fendler, MD
- Not yet recruiting
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017
Xochitl Quintero, 213-977-2121 ext. 2584, xochitl.quintero@pihhealth.org
Joseph Rahman, MD
- Recruiting
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
Melissa Slager, 715-389-3531, Melissa.Slager@SanfordHealth.org
- Recruiting
Cardiology Associates of Mobile
Mobile, Alabama, 36608
Lynn Ward, RN, 251-340-6870, lynnward@cardassoc.com
Kenneth Burnham, MD
- Recruiting
Cardiovascular Medicine
Moline, Illinois, 61265
Mark Shen, MD, (309)-743-6764, research@cvmedpc.com
Mark Shen, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Bridget Langenfeld, 402-836-9364, brlangenfeld@unmc.edu
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
AdventHealth Research Institute, 407-303-7193, CFD.TRI.Recruitment@AdventHealth.com
Stacy Mandras, MD
- Recruiting
North Central Heart
Sioux Falls, South Dakota, 57108
Patty Eisenbraun, 605-977-5000, research@ncheart.com
Orvar Jonsson, MD
- Recruiting
Tallahassee Research Institute
Tallahassee, Florida, 32308
Wendie Najdowski, 850-431-5024, wendie.najdowski@tmh.org
Gian-Carlo Giove, MD
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Courtney Nicholas, 813-844-4914, courtneynicholas@tgh.org
- Recruiting
BayCare Health Systems
Tampa, Florida, 33614
Haydy Rojas Paz, RN, 813-533-1444, Haydy.RojasPaz@Baycare.org
Laurie Letarte, MD
- Not yet recruiting
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Mayra Sandoval, 918-502-1602, msandovaltovar@saintfrancis.com
Douglas Ensley, MD
- Recruiting
CHRISTUS Trinity Mother Frances
Tyler, Texas, 75701
Jamie-Crystal Wylie, 903-606-3737, JamieCrystal.Wylie@CHRISTUSHealth.org
John Sims, MD
About this study
Official title: 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).
- Being tested
- Barostim System, Usual care medical management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barostim SystemDevice
Baroreflex Activation Therapy (BAT) using the Barostim System
Usual care medical managementOther
Usual care medical management alone - no device implant
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management. Receives: Device: Barostim System |
| Control Arm | Active comparator | Participants will receive usual care medical management alone with no Barostim System device implant. Receives: Other: Usual care medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Composite of all-cause mortality and Heart Failure Morbidity, defined as Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events, assessed through 24 months of follow-up.
Measured: Through 24-months follow-up
Primary Safety Endpoint
The event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 180 days of the device implant, assessed among participants who were randomized to the Device Arm and in whom an implant has been achieved or attempted.
Measured: Within 180 days of the device implant
Secondary outcomes (5)
Quality of Life (QoL) Score Change
QoL score change from baseline to 12 months, measured by the Minnesota Living With Heart Failure (MLWHF) questionnaire, a 21-question survey that uses a 0-5 scale where a lower score indicates better QoL.
Measured: 12-months follow-up
6MHW distance change
6-minute hall walk (6MHW) distance change from baseline to 12 months.
Measured: 12-months follow-up
Days lost to death or hospitalization
Measured: 24-months follow-up
NT-proBNP level change
NT-proBNP level change from baseline to 12 months
Measured: 12-months follow up
All-cause mortality
All-cause mortality rate for all randomized participants through 24-months of follow-up.
Measured: 24-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start24 Apr 2026
- Primary completionJan 2033 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, multicenter clinical trial. Eligible participants will be randomized in a 2:1 ratio to receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management (Device Arm) or to receive usual care medical management alone with no device implant (Control Arm).
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232030
- Sponsor's protocol ID
- 360069-001
- Acronym
- BENEFIT-HF
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No