Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCVRx, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
Any contraindications to Barostim as noted in Instructions for Use.
An existing device which contraindicates Barostim specifically or unipolar therapy in general.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Barostim System
DeviceBaroreflex Activation Therapy (BAT) using the Barostim System
Usual care medical management
Other interventionUsual care medical management alone - no device implant
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: Device ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through 24-months follow-up2
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.
Time frame
Within 180 days of the device implantSecondary outcomes
1
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.
Time frame
12-months follow-up2
6MHW distance change
6-minute hall walk (6MHW) distance change from baseline to 12 months.
Time frame
12-months follow-up3
Days lost to death or hospitalization
Time frame
24-months follow-up4
NT-proBNP level change
NT-proBNP level change from baseline to 12 months
Time frame
12-months follow up Source ClinicalTrials.gov