Baroreflex Activation Therapy for Heart Failure

(BREATHE-HF Trial)

Not yet recruiting at 6 trial locations

Overseen By Morgan Smith, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: GDMT medications

Must not be taking: Inotropes

Disqualifiers: Myocardial infarction, Severe chronic lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Barostim, which might help people with heart failure. Heart failure hinders the heart's ability to pump blood efficiently, and this device aims to improve heart function and enhance exercise tolerance. The trial seeks adults diagnosed with heart failure who experience symptoms like shortness of breath or fatigue. Participants should already be on optimal medication for heart failure. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future heart failure treatments.

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 that participants should be on maximally-tolerated guideline-directed medical therapies. It's best to discuss your specific medications with the trial team.

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

Research has shown that Baroreflex Activation Therapy (BAT) is safe for people with heart failure. Studies indicate that this therapy can enhance patient well-being and exercise capacity. Importantly, it maintains a strong safety record. For instance, one study showed that the therapy lowered blood pressure without causing serious side effects. Another study found similar results, noting improvements in heart function and quality of life. Overall, these findings suggest that patients tolerate BAT well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Baroreflex Activation Therapy is unique because it targets the nervous system to help manage heart failure, unlike most current treatments that focus on the heart itself or systemic symptoms. This therapy involves the implantation of the Barostim™ device, which stimulates baroreceptors in the neck to balance the nervous system and improve heart function. Researchers are excited because this approach could offer better symptom control and potentially improve quality of life for patients with heart failure, providing an innovative alternative to traditional medications and invasive procedures.

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

Research has shown that Baroreflex Activation Therapy (BAT) can improve heart function and quality of life for people with heart failure. Studies have found that this therapy helps patients walk longer and reduces hospital visits. The BeAT-HF trial confirmed that BAT is safe and enhances exercise capacity while reducing symptoms. Patients using this therapy often experience better well-being and improved heart health. Overall, Baroreflex Activation Therapy appears promising for supporting those with heart failure. ^{1 2 6 7 8}

Who Is on the Research Team?

Nir Uriel, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults with heart failure where the heart's pumping power is reduced (ejection fraction ≤ 35%). Participants must be on full doses of standard heart failure treatments, have a certain level of NT-proBNP (a heart stress marker), and fall within specific categories of symptom severity. People under 18 or those not meeting these criteria cannot join.

Inclusion Criteria

My NT-proBNP level is below 1600 pg/ml within the last 3 months.

My heart's pumping ability is significantly reduced.

My heart condition is classified as NYHA Class II or III.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Titration

Participants undergo implantation of the Barostim™ system, followed by device programming and titration

3 months

Post-Titration Monitoring

Participants are monitored for changes in cardiac output, PCWP, and other parameters approximately 6 months after device titration

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Baroreflex Activation Therapy

Trial Overview

The study tests Baroreflex Activation Therapy using the CVRx Barostim device in patients with severe heart failure. It looks at how this therapy affects their heart function, symptoms, and ability to exercise by monitoring blood flow and pressures during physical activity.

How Is the Trial Designed?

Group I: Barostim™ Therapy Experimental Treatment 1 Intervention

Participants will undergo implantation of the Barostim™ system, followed by device programming and titration according to standard clinical practice for up to three months after implantation.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

CVRx, Inc.

Industry Sponsor

Trials

21

Recruited

8,500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7083497/

Safety and efficacy of baroreflex activation therapy for heart ...

The results indicate that the therapy is safe and improves clinical outcomes such as NYHA class of HF, quality of life, 6 min walk test, and hospitalization ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071916425000557

Real-World Analysis of Health Care Utilization With ...

The BeAT-HF trial (Baroreflex Activation Therapy for Heart Failure) demonstrated the safety and efficacy of BAT in improving exercise capacity, quality of life, ...

3.

jacc.org

jacc.org/doi/10.1016/j.jaccas.2024.103090

2-Year Follow-Up of Baroreflex Activation Therapy for ...

Although recent results from the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial show positive outcomes, BAT remains underused., This report ...

4.

barostim.com

barostim.com/wp-content/uploads/2024/05/European-J-of-Heart-Fail-2024-Zile-Baroreflex-activation-therapy-in-patients-with-heart-failure-and-a-reduced.pdf

Baroreflex activation therapy in patients with heart failure ...

Long-term vagal stimulation for heart failure: Eighteen month results from the NEural cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02627196

Baroreflex Activation Therapy for Heart Failure (BeAT-HF)

The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence ...

6.

barostim.com

barostim.com/wp-content/uploads/2022/02/Are-Intermediate-Endpoints-Associated-With-Serious-Adverse-Cardiovascular-Events-Preliminary-Results-From-The-BeAT-HF-Trial.pdf

Baroreflex Activation Therapy for the Treatment of Heart ...

Outcomes • BAROSTIM Therapy is safe. • Mechanism of action demonstrated through muscle sympathetic nerve activity & HR. Variability. • BAROSTIM Therapy is safe ...

7.

acc.org

acc.org/Latest-in-Cardiology/Articles/2022/12/02/13/14/Barostim-Baroflex-Activation-Therapy

Barostim Baroreflex Activation Therapy

reduced mean BP by 21/12 mmHg after 3 months of therapy with a favorable safety profile. ... While the endpoints of sustained efficacy, BAT safety ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02627196

NCT02627196 | Baroreflex Activation Therapy for Heart ...

The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence ...