Baroreflex Activation Therapy for Heart Failure

(BAT-VAD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Baroreflex Activation Therapy (BAT) affects individuals with heart failure who have a left ventricular assist device (LVAD). BAT may help manage heart issues by activating a device that influences the body's blood pressure reflexes. Participants will have their BAT device activated for three months and then deactivated for another three months to compare results. This trial suits LVAD patients who have had their pump for over three months and already have a BAT device implanted.

As an unphased trial, this study offers a unique opportunity for patients to contribute to groundbreaking research that could enhance heart failure management.

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 prior data suggests that this device is safe for heart failure patients?

Research has shown that Baroreflex Activation Therapy (BAT) is generally safe. In one study, patients who received BAT experienced improvements in heart failure symptoms, better quality of life, and fewer hospital visits. Importantly, the study reported no serious side effects. Another study on BAT for resistant hypertension found it to be safe. In the trials reviewed, BAT was well-tolerated and did not cause major problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Baroreflex Activation Therapy (BAT) is unique because it directly targets the body's baroreceptors, which are sensors in your blood vessels that help regulate blood pressure. Unlike typical heart failure treatments that often focus on reducing fluid overload or altering heart rate, BAT aims to improve the body's natural reflexes to stabilize blood pressure and heart function. Researchers are excited about this therapy because it offers a new mechanism of action that could complement existing treatments, potentially improving outcomes for patients with heart failure who don't respond well to standard therapies.

What evidence suggests that Baroreflex Activation Therapy is effective for heart failure?

Research has shown that Baroreflex Activation Therapy (BAT) can help people with heart failure. In this trial, participants will join either a treatment arm where BAT is activated or a control arm where BAT remains inactive. Studies have found that BAT can improve the New York Heart Association (NYHA) class, a measure of heart failure severity, and enhance patients' quality of life. Participants using BAT have walked longer during the 6-minute walk test, a common assessment of heart failure impact. Additionally, BAT has reduced hospital visits, offering significant benefits for patients. Overall, BAT has proven safe and effective in managing heart failure symptoms. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Brian Houston

Lead Sponsor

Trials

1

Recruited

10+

CVRx, Inc.

Industry Sponsor

Trials

21

Recruited

8,500+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3384947/

Baroreflex Activation Therapy for the Treatment of Drug- ... In a single-center study, BAT showed a pronounced BP decrease of even 53/30 mmHg after 4 years of continuous therapy in subjects with drug- ...

4. uscjournal.com uscjournal.com/articles/baroreflex-activation-therapy-resistant-hypertension-and-heart-failure?language_content_entity=en

Baroreflex Activation Therapy for Resistant Hypertension ... Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled ...

5. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.124.23088

Sham-Controlled Randomized Pilot Trial on Baroreflex ... In conclusion, our study suggests that BAT lowers BP in individuals with RH and calls for larger, well-performed, randomized, sham-controlled ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02627196

Baroreflex Activation Therapy for Heart Failure (BeAT-HF) The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with ...