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Barostim-drevet Nevrohormonell Intervensjon for Forbedring av Hjertesviktbehandling (BENEFIT-HF)

6. november 2026 oppdatert av: CVRx, Inc.

Barostim-drevet nevrohormonell intervensjon for forbedret behandling av hjertesvikt (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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

2500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36608
        • Rekruttering
        • Cardiology Associates of Mobile
        • Ta kontakt med:
        • Hovedetterforsker:
          • Kenneth Burnham, MD
    • California
      • Los Angeles, California, Forente stater, 90033
        • Rekruttering
        • Keck School of Medicine of USC
        • Hovedetterforsker:
          • Michael Fong, MD
        • Ta kontakt med:
      • Los Angeles, California, Forente stater, 90017
        • Rekruttering
        • PIH Health Good Samaritan Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Joseph Rahman, MD
    • Florida
      • Clearwater, Florida, Forente stater, 33756
        • Rekruttering
        • BayCare Health System
        • Hovedetterforsker:
          • Leslie Miller, MD
        • Ta kontakt med:
      • Jacksonville, Florida, Forente stater, 32256
        • Rekruttering
        • First Coast Cardiovascular Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Sumant Lamba, MD
      • Orlando, Florida, Forente stater, 32803
        • Rekruttering
        • AdventHealth Orlando
        • Hovedetterforsker:
          • Stacy Mandras, MD
        • Ta kontakt med:
      • Tallahassee, Florida, Forente stater, 32308
        • Rekruttering
        • Tallahassee Research Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Gian-Carlo Giove, MD
      • Tampa, Florida, Forente stater, 33606
        • Rekruttering
        • Tampa General Hospital
        • Ta kontakt med:
      • Tampa, Florida, Forente stater, 33614
        • Rekruttering
        • BayCare Health Systems
        • Hovedetterforsker:
          • Laurie Letarte, MD
        • Ta kontakt med:
    • Illinois
      • Elk Grove Village, Illinois, Forente stater, 60007
        • Rekruttering
        • Ascension Alexian Brothers
        • Hovedetterforsker:
          • Ashish Haryani, MD
        • Ta kontakt med:
      • Moline, Illinois, Forente stater, 61265
        • Rekruttering
        • Cardiovascular Medicine
        • Hovedetterforsker:
          • Mark Shen, MD
        • Ta kontakt med:
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46260
        • Rekruttering
        • Ascension St. Vincent
        • Hovedetterforsker:
          • Ashwin Ravichandran, MD
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Rekruttering
        • Tufts Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Michael S. Kiernan, MD
    • Missouri
      • Kansas City, Missouri, Forente stater, 64111
        • Har ikke rekruttert ennå
        • Saint Luke's Hospital of Kansas City
        • Hovedetterforsker:
          • Timothy Fendler, MD
        • Ta kontakt med:
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • Rekruttering
        • University of Nebraska Medical Center
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10032
        • Har ikke rekruttert ennå
        • Columbia University Medical Center/NewYork Presbyterian Hospital
        • Hovedetterforsker:
          • Gabriel Sayer, MD
        • Ta kontakt med:
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74136
        • Har ikke rekruttert ennå
        • Saint Francis Hospital
        • Hovedetterforsker:
          • Douglas Ensley, MD
        • Ta kontakt med:
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57108
        • Rekruttering
        • North Central Heart
        • Hovedetterforsker:
          • Orvar Jonsson, MD
        • Ta kontakt med:
    • Tennessee
      • Chattanooga, Tennessee, Forente stater, 37403
        • Rekruttering
        • Erlanger Health
        • Ta kontakt med:
        • Hovedetterforsker:
          • Patrick Stevens, MD
      • Germantown, Tennessee, Forente stater, 38138
        • Rekruttering
        • Stern Cardiovascular Center
        • Hovedetterforsker:
          • Frank McGrew, MD
        • Ta kontakt med:
    • Texas
      • Tyler, Texas, Forente stater, 75701
        • Rekruttering
        • CHRISTUS Trinity Mother Frances
        • Hovedetterforsker:
          • John Sims, MD
        • Ta kontakt med:
    • Wisconsin
      • Marshfield, Wisconsin, Forente stater, 54449

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Device Arm

Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management.
Enhet: Barostim System

Baroreflex Activation Therapy (BAT) using the Barostim System
Aktiv komparator: Control Arm

Participants will receive usual care medical management alone with no Barostim System device implant.
Annen: Usual care medical management

Usual care medical management alone - no device implant

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Effectiveness Endpoint
Tidsramme: Through 24-months follow-up

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.
Through 24-months follow-up
Primary Safety Endpoint
Tidsramme: Within 180 days of the device implant

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.
Within 180 days of the device implant

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dager tapt på grunn av død eller innleggelse
Tidsramme: 24-måneders oppfølging
24-måneders oppfølging
Quality of Life (QoL) Score Change
Tidsramme: 12-months follow-up

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.
12-months follow-up
6MHW distance change
Tidsramme: 12-months follow-up

6-minute hall walk (6MHW) distance change from baseline to 12 months.
12-months follow-up
NT-proBNP level change
Tidsramme: 12-months follow up

NT-proBNP level change from baseline to 12 months
12-months follow up
All-cause mortality
Tidsramme: 24-months follow-up

All-cause mortality rate for all randomized participants through 24-months of follow-up.
24-months follow-up

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CVRx, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. april 2026

Primær fullføring (Antatt)

1. januar 2033

Studiet fullført (Antatt)

1. januar 2033

Datoer for studieregistrering

Først innsendt

14. november 2025

Først innsendt som oppfylte QC-kriteriene

14. november 2025

Først lagt ut (Faktiske)

18. november 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 360069-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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