15 Participants Needed

BaroStim for Heart Failure

MM
SS
Overseen ByShreya Srivastava, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a device called BaroStim to help manage heart failure symptoms. BaroStim stimulates the body's natural reflexes to improve heart function. The trial seeks individuals diagnosed with NYHA Class III heart failure who have had a CardioMems device inserted in the past three months. Those who fit this description and can handle oral medications might be suitable for this study. As a Phase 2, Phase 3 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group and is in the final step before FDA approval. This offers participants a chance to contribute to a potentially groundbreaking heart failure treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions a period of medication management and optimization. It's best to discuss your specific medications with the trial team.

What prior data suggests that the BaroStim device is safe for heart failure patients?

Research has shown that BaroStim is safe for people with heart failure. Studies have found that it can improve quality of life and enhance heart function. Most importantly, it is well-tolerated, with most people experiencing no serious side effects.

For those with heart failure, BaroStim reduces symptoms and improves heart function. This evidence suggests that BaroStim is a safe option for enhancing heart health in eligible patients.1234

Why do researchers think this study treatment might be promising?

BaroStim is unique because it uses a novel approach to manage heart failure by targeting the autonomic nervous system. Unlike standard treatments like beta-blockers or ACE inhibitors, which primarily focus on heart function and blood pressure, BaroStim works by stimulating baroreceptors, which are sensors in your blood vessels that help regulate heart rate and blood pressure. This method offers a new way to potentially improve heart function and quality of life for patients with NYHA Class III heart failure. Researchers are excited about BaroStim because it provides a non-drug option that could complement existing therapies and offer relief to patients who haven't responded well to traditional treatments.

What evidence suggests that the BaroStim device is effective for heart failure?

Research has shown that BaroStim, a therapy activating certain body reflexes, benefits people with heart failure. Studies indicate it improves heart function and quality of life. Participants in this trial will receive BaroStim, and previous research demonstrated that patients using BaroStim experienced fewer serious heart problems compared to those who did not. Evidence also shows it reduces heart strain, as indicated by lower levels of NT-proBNP, a substance linked to heart failure. Real-world data suggests BaroStim helps reduce hospital visits for heart issues. Overall, BaroStim appears to be a promising option for managing heart failure.34567

Who Is on the Research Team?

JK

John Kassotis, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for heart failure patients who have had a CardioMems device inserted and undergone 3 months of medication management. Ideal candidates are those now considered for BaroStim therapy, which aims to optimize heart function.

Inclusion Criteria

I can take pills for my treatment.
Provision of signed and dated informed consent form
I am willing and able to follow all study requirements.
See 4 more

Exclusion Criteria

NT-proBNP >1600 mg/dL
Indicated for CRT-D device (left bundle branch block)
Left ventricular assist device (LVAD)
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

At the time of CardioMems insertion

Medication Management

Patients undergo 3 months of medication management and titration after CardioMems insertion

3 months
Regular in-office visits for medication titration

BaroStim Insertion and Titration

Insertion and titration of BaroStim device, with monitoring of pulmonary artery diastolic pressure, 6MWT, and vital signs

1 year
In-office visits for titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after BaroStim insertion

1 year
Regular clinic visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • BaroStim

Trial Overview

The study tests the effectiveness of BaroStim in managing Heart Failure (HFrEF) by monitoring changes with CardioMems, which measures lung artery pressure. Patients will be observed for one year after receiving the BaroStim device.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BaroStimExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Citations

Baroreflex Activation Therapy for the Treatment of Heart ...

➢ Within the first six months, BAT patients had significantly fewer serious cardiovascular adverse events than the Control patients. ➢ The ongoing BEAT-HF trial ...

Efficacy and safety of baroreflex activation therapy for heart ...

The results show that BAT is safe and improves functional class, quality of life and congestion in selected patients with HFrEF.

Response to Baroreflex Activation Therapy (BAT) By Atrial ...

➢ These results were supported by objective evidence of significant reduction of NT-proBNP. ➢ BAT is equally safe and effective in patients with or without ...

Study Details | NCT07232030 | Barostim-Enabled ...

The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in ...

Real world evidence demonstrates significant reduction in ...

This analysis of a large all-payer database suggests that implantation of Barostim is associated with significant reductions in all-cause, cardiovascular, and ...

Important Safety & Regulatory Information

The Barostim System is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline- ...

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

The BAROSTIM NEO® System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and ...