Impact of Barostim on heart function in adults with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter interventional study examining the effects of baroreflex activation therapy using the Barostim device in adults with heart failure and reduced ejection fraction. Participants have EF ≤ 35% and remain symptomatic despite optimized medical and device therapy. The study uses invasive hemodynamics via right heart catheterization, along with measurements of exercise capacity and response to medical therapy, to understand mechanistic and clinical outcomes. The goal is to inform patient selection and device management for this therapy in heart failure care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
* Symptoms consistent with one of:

  1. current New York Heart Association (NYHA) Class III or
  2. current NYHA Class II and historical NYHA Class III
* Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \< 1600 pg/ml (should be within 3 months of screen)
* Management with maximally-tolerated GDMT medications and devices
* Age \>= 18 years

Exclusion Criteria:

* Age \< 18 years
* Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
* Bilateral carotid bifurcations located above the level of the mandible
* Carotid artery stenosis greater than 50% caused by atherosclerosis
* Ulcerative plaques in the carotid artery
* Baroreflex failure or autonomic neuropathy
* Symptomatic un-controlled bradyarrhythmias
* Severe chronic lung disease
* Current treatment with inotropes
* Pacemaker or ICD within 3 months of screening
* Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
* Prior surgery, radiation, endovascular stent in the carotid sinus
* History or consideration of solid organ transplantation
* History or consideration of left ventricular assist device (LVAD)
* Life expectancy \<1 year from time of screening
* Non-cardiovascular conditions interfering with 6MWT distance assessment
* Inability to fulfill protocol requirements
* Known allergy to silicone or titanium

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting
• University of California San Francisco Health
  San Francisco, California, United States Not yet recruiting
• MedStar Health
  Washington D.C., District of Columbia, United States Not yet recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Not yet recruiting
• Weill Cornell Medicine
  New York, New York, United States Not yet recruiting
• Montefiore Medical Center
  New York, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Nir Uriel, MD — Columbia University
• Study coordinator: Morgan Smith, MD
• Email: mds2225@cumc.columbia.edu
• Phone: 914-629-3121

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Guideline Adherence in HFrEF: See If Mirror Information Helps Doctors and Patients Follow GDMT

  This study tests whether showing doctors, or both doctors and patients, mirror information about how well guideline-directed medical therapy is being used in heart failure with reduced ejection fraction.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07702760

• Eccentric Muscle Training in Cardiac Rehab for Heart Failure with Reduced Ejection Fraction

  This study tests eccentric overload and eccentric cycling as part of a cardiac rehabilitation program for people with HFrEF to see if they build more muscle strength and mass than traditional training.

  Recruiting University Hospital, Antwerp · Edegem · NCT07636343

• Predicting who improves after phase II cardiac rehabilitation for reduced ejection fraction

  This project will test whether blood microRNA patterns together with non-invasive exercise measurements can predict which people with reduced ejection fraction heart failure will improve their peak oxygen uptake after a phase II cardiac rehab program.

  Recruiting Centre Hospitalier de Corbie · Corbie · NCT07164911

• Swedish heart and kidney failure pilot

  This trial will test whether the drug eplerenone is safe and feasible for people with heart failure with reduced ejection fraction who also have severe chronic kidney disease.

  Recruiting Phase 2 Karolinska Institutet · Stockholm · NCT07029503

• Exploring heart failure and diabetes interactions

  This study looks at how heart failure and diabetes affect the body differently by testing 600 people with various combinations of these conditions.

  Recruiting University of Leeds · Leeds, West Yorkshire · NCT06774014

• AI-based assessment of heart function using ECG wearable monitors

  This study tests if a new AI tool using a wearable heart monitor can accurately check heart function in people with heart failure compared to traditional heart scans.

  Recruiting at 8 sites Peerbridge Health, Inc · Orange, California and 7 other locations · NCT06699056

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.