Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseinterventionalRules rewrite
Not a traditional drug phase: Barostim System for Heart Failure
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).
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Barostim System, or Usual care medical management. The registry lists allocation as randomized. 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).
They plan to enroll about 2,500 people at 23 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)
Interventions: Barostim System, Usual care medical management
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 body-mass index (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 body-mass index (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 body-mass index (BMI) using a 4% reduction per body-mass index (BMI) unit over 25 kg/m2
Who the registry excludes
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
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers.
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to measure the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07232030?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07232030?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.