Baroreflex Activation Therapy for Heart Failure

(BAT-VAD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brian Houston

Disqualifiers: Cardiogenic shock, Respiratory failure, Hypotension, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will involve LVAD patients who have already received a clinically-indicated BAT (BAROSTIM) device. After recovery from LVAD implant, we will investigate the effects of BAT in a double-blind cross-over study design.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Baroreflex Activation Therapy (BAT) for heart failure?

Research shows that Baroreflex Activation Therapy (BAT) can improve heart failure symptoms, reduce hospitalization rates, and enhance walking distance in patients with heart failure. It also helps in lowering blood pressure in patients with resistant hypertension, although more large-scale studies are needed to fully understand its long-term benefits and safety. ^{1 2 3 4 5}

Is Baroreflex Activation Therapy (BAT) safe for humans?

Baroreflex Activation Therapy (BAT) has been studied for conditions like resistant hypertension and heart failure. Some studies suggest it is safe and can improve symptoms, but large trials are still needed to fully understand its safety and effectiveness. ^{1 2 3 4 6}

How does baroreflex activation therapy differ from other treatments for heart failure?

Baroreflex activation therapy (BAT) is unique because it uses a device to electrically stimulate the carotid sinus, which helps balance the nervous system by reducing excessive sympathetic activity (part of the nervous system that can increase heart rate and blood pressure). Unlike traditional medications, BAT directly targets the autonomic nervous system to improve heart function and reduce symptoms in heart failure patients. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for adults over 18 with heart failure who have had a left ventricular assist device (LVAD) implanted for at least 3 months and already have a BAROSTIM device. It's not suitable for those in shock, with severe breathing problems, very low blood pressure, slow heartbeat, suspected pump clotting or serious irregular heartbeats.

Inclusion Criteria

Existing BAT device

I am older than 18 years.

I have had my LVAD implant for more than 3 months.

Exclusion Criteria

I have severe heart or lung problems, like shock or unstable heart failure.

Bradycardia (resting HR <60 beats/minute)

Presence of suspected pump thrombosis at the time of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (BAT off)

Baroreflex activation therapy turned off for three months

3 months

Regular monitoring visits

Treatment (BAT on)

Baroreflex activation therapy turned on for three months

3 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Baroreflex Activation Therapy (BAT)

Trial Overview The study tests the effects of Baroreflex Activation Therapy (BAT) on patients with LVADs using a double-blind cross-over design. This means neither the researchers nor participants know when the BAT is active as they switch between 'on' and 'off' periods.

Participant Groups

Group I: treatment (BAT on) Experimental Treatment 1 Intervention

Baroreflex activation therapy turned on for three months

Group II: control (BAT off) Placebo Group 1 Intervention

Baroreflex activation therapy turned off for three months

Who Is Running the Clinical Trial?

Brian Houston

Lead Sponsor

Trials

1

Recruited

10+

CVRx, Inc.

Industry Sponsor

Trials

21

Recruited

8,500+

Findings from Research

Baroreflex activation therapy (BAT) has shown promise in lowering blood pressure in patients with therapy-resistant hypertension (rsHTN) and improving symptoms in those with severe heart failure, but large randomized trials are still needed to confirm its efficacy and safety.

The existing studies, including the Rheos Pivotal Trial and a smaller heart failure study, indicate that BAT can be beneficial, yet the lack of extensive data on the Barostim Neo system limits definitive conclusions about its long-term effects and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Baroreflex activation therapy : Indication and evidence in resistant hypertension and heart failure]. Wallbach, M., Koziolek, MJ., Wachter, R.[2019]

In a follow-up study of 7 heart failure patients over approximately 43.5 months, baroreflex activation therapy (BAT) significantly reduced muscle sympathetic nerve activity (MSNA), bringing levels close to those of healthy controls, indicating improved sympathetic function.

BAT also led to a significant reduction in hospitalization rates, from an average of 10.3 days per year to just 1.01 days, while improving left ventricular ejection fraction from 32.3% to 36.7%, with no reported side effects during the long-term follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of normal sympathetic neural function in heart failure following baroreflex activation therapy: final 43-month study report. Dell'Oro, R., Gronda, E., Seravalle, G., et al.[2018]

Carotid baroreflex activation therapy (BAT) has shown promising results in reducing blood pressure and heart rate in patients with resistant hypertension, with recent advancements indicating that unilateral stimulation can be as effective as bilateral stimulation.

The second-generation Barostim neo device uses a new carotid electrode for unilateral activation, leading to significant improvements in cardiac parameters, but further research is needed to understand why not all patients respond positively to BAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy for the treatment of drug-resistant hypertension: new developments. Alnima, T., de Leeuw, PW., Kroon, AA.[2021]

The Barostim Neo™ device for baroreflex activation therapy (BAT) was safely implanted in 30 patients with heart failure with reduced ejection fraction (HFrEF), leading to significant improvements in clinical symptoms and modest improvements in left ventricular function over 12 months.

Despite these improvements, the risk of death remained high, particularly in patients with advanced heart failure (NYHA Class IV) and elevated NT-proBNP levels, highlighting the importance of careful patient selection for BAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience. Blanco, C., Madej, T., Mangner, N., et al.[2023]

Baroreflex activation therapy (BAT) has been shown to provide long-term benefits in patients with heart failure and reduced ejection fraction (HFrEF), including sustained reductions in muscle sympathetic nerve activity and hospitalization rates over a follow-up period of approximately 21.5 months.

The study indicates that BAT not only improves clinical outcomes and quality of life but also suggests a potential cause-and-effect relationship between the therapy and the observed reductions in sympathetic activity, warranting further investigation in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. Gronda, E., Seravalle, G., Trevano, FQ., et al.[2019]

In a study involving 11 patients with advanced heart failure, baroreflex activation therapy (BAT) significantly reduced muscle sympathetic nerve activity by 31% and improved heart function and quality of life over 6 months.

BAT was found to be safe, with only one complication reported, and it may enhance outcomes in heart failure by restoring autonomic balance, warranting further randomized trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Gronda, E., Seravalle, G., Brambilla, G., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Baroreflex activation therapy : Indication and evidence in resistant hypertension and heart failure]. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Restoration of normal sympathetic neural function in heart failure following baroreflex activation therapy: final 43-month study report. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy for the treatment of drug-resistant hypertension: new developments. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. [2021]