Renal Denervation for High Blood Pressure

(REDUCED Trial)

Not currently recruiting at 8 trial locations

Overseen By Ajay Kirtane, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SoniVie Inc.

Must be taking: Antihypertensives

Must not be taking: NSAIDs, Immunosuppressives, Anticoagulants

Disqualifiers: Renal abnormalities, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the TIVUS™ System to determine its safety and effectiveness in lowering high blood pressure. It focuses on individuals with stage 2 hypertension (uncontrolled high blood pressure) who haven't found relief with current medications. The treatment uses ultrasound (sound waves) to target nerves around the kidney's blood vessels. Ideal candidates are those on blood pressure medication who still experience high readings but don't have certain kidney or heart conditions. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those seeking new solutions.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires that you maintain your anti-hypertensive medication regimen for at least 3 months.

What prior data suggests that the TIVUS™ System is safe for renal denervation?

Research has shown that the TIVUS™ System, a device using ultrasound for kidney treatment, has undergone safety testing in earlier studies. One study found that after a year, the device was generally safe and steadily lowered blood pressure. Another study confirmed that this ultrasound treatment was safe and effective, consistently reducing the systolic blood pressure.

These results suggest that the TIVUS™ System is well-tolerated, with no major problems reported in these studies. However, like any medical procedure, some risks may exist, so discussing these with the clinical trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Renal denervation using the TIVUS™ System is unique because it utilizes unfocused ultrasound to target the sympathetic nerves surrounding the renal arteries. This is different from current treatments for high blood pressure, like medications that often work by altering hormone levels or kidney function. The innovative use of ultrasound offers a non-drug approach, potentially reducing side effects associated with long-term medication use. Researchers are excited about this treatment because it may provide a more durable solution to high blood pressure by directly addressing nerve activity, offering hope for patients who do not respond well to conventional therapies.

What evidence suggests that the TIVUS™ System is effective for high blood pressure?

Research has shown that the TIVUS™ System, tested in this trial for renal denervation, uses sound waves to target nerves around the kidney's blood vessels and can effectively lower blood pressure. One study found that patients experienced a significant drop in blood pressure 12 months after treatment. Additionally, a review of several studies concluded that this type of sound wave treatment works well for individuals whose high blood pressure does not improve with other treatments. These findings suggest that the TIVUS™ System could be a promising option for managing high blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Ajay Kirtane, MD

Principal Investigator

Columbia University/NYPH

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with stage 2 hypertension, who have high blood pressure despite taking medication. Participants should be willing to maintain their current medication regimen and comply with study procedures. Pregnant women, individuals planning major surgeries, those on certain anticoagulants or with severe kidney issues are excluded.

Inclusion Criteria

Patient is able and willing to comply with all study procedures.

Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure

My average daytime blood pressure is between 135 and 179 mm Hg after a month of monitoring.

Exclusion Criteria

I have not had an infection in the week before my procedure.

I have a heart valve problem that could worsen with sudden blood pressure drops.

I have not had major surgery or heart-related procedures in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo renal denervation using the TIVUS™ System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are monitored for changes in blood pressure and renal function

36 months

What Are the Treatments Tested in This Trial?

Interventions

• TIVUS™ System

Trial Overview The REDUCED 1 trial tests the TIVUS™ System's safety and effectiveness in lowering blood pressure through renal denervation—a procedure that disrupts nerve signals contributing to high blood pressure. The focus is on changes in daytime systolic blood pressure after three months.

How Is the Trial Designed?

Group I: Renal denervation Experimental Treatment 1 Intervention

Denervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound

Who Is Running the Clinical Trial?

SoniVie Inc.

Lead Sponsor

Trials

6

Recruited

540+

Published Research Related to This Trial

Renal denervation is a promising device-based procedure for treating hypertension, showing safety and efficacy in recent clinical trials with new-generation devices, although its clinical use remains debated.

The Italian Society of Arterial Hypertension recommends careful patient selection for renal denervation, considering factors like blood pressure, cardiovascular risk, medication adherence, and patient preferences, while emphasizing the need for further studies to validate these recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Italian Society of Arterial Hypertension (SIIA) Position Paper on the Role of Renal Denervation in the Management of the Difficult-to-Treat Hypertensive Patient. Bruno, RM., Taddei, S., Borghi, C., et al.[2020]

The DENEX™ renal sympathetic denervation system demonstrated a favorable safety profile in a pilot study involving 16 patients with resistant hypertension, with no major adverse events reported during the 6-month follow-up.

Patients experienced a significant reduction in office systolic blood pressure (SBP) from 164.6 mmHg to 142.0 mmHg after 3 months, indicating the efficacy of the DENEX™ system in managing resistant hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX™ in Patients with Uncontrolled Hypertension on Standard Medical Therapy. Kim, CJ., Chang, K., Kim, BK., et al.[2021]

The second generation EnligHTN Renal Denervation System safely reduced office blood pressure in patients with drug-resistant hypertension, showing significant decreases at multiple time points up to 24 months after the procedure.

No serious adverse events related to the device or procedure were reported, indicating a favorable safety profile for this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension. Worthley, SG., Wilkins, GT., Webster, MW., et al.[2022]

Early trials of renal denervation showed significant reductions in blood pressure, suggesting a potential benefit for treating hypertension.

However, later studies comparing renal denervation to sham procedures yielded neutral results, indicating that current evidence is insufficient to establish it as a standard clinical therapy for hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rise, fall, and possible resurrection of renal denervation. Gulati, R., Raphael, CE., Negoita, M., et al.[2018]

In a review of 50 trials involving 5,769 subjects, the rate of renal artery adverse events following renal denervation was found to be very low, with only 0.45% of patients experiencing renal artery stenosis or dissection.

The annual incidence rate of stent implantation after renal denervation was just 0.20%, indicating that serious complications are rare, and most adverse events occurred within the first year after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation. Townsend, RR., Walton, A., Hettrick, DA., et al.[2021]

The Vessix Renal Denervation System significantly reduced office blood pressure by an average of 24.7 mmHg and ambulatory blood pressure by 8.4 mmHg after six months in patients with resistant hypertension, demonstrating its efficacy.

The procedure showed a favorable safety profile, with no serious renal artery injuries or significant changes in renal function, as indicated by stable eGFR levels, although one case of renal artery stenosis required stenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. Sievert, H., Schofer, J., Ormiston, J., et al.[2022]

In a study of 46 patients with drug-resistant hypertension, the multi-electrode ablation system for renal denervation led to significant reductions in blood pressure over 24 months, with office BP decreasing by an average of -29/-13 mmHg.

The procedure was found to be safe, with no new serious device or procedure-related adverse events reported, indicating that renal denervation can be a reliable treatment option for patients with difficult-to-treat hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter-based renal denervation for resistant hypertension: Twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system. Tsioufis, CP., Papademetriou, V., Dimitriadis, KS., et al.[2022]

Renal denervation therapy (RDN) has been found to be safe for patients with resistant hypertension, but its effectiveness in lowering blood pressure is variable and not significantly better than standard medical therapy.

Recent studies and ongoing trials are focusing on improving the procedural aspects of RDN and identifying patients who truly have treatment-resistant hypertension, which may help uncover potential benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status of Renal Denervation in Hypertension. Briasoulis, A., Bakris, GL.[2018]

Citations

1. journals.lww.com journals.lww.com/jhypertension/fulltext/2025/05001/12_month_results_of_the_reduced_1_trial_assessing.45.aspx

12-month results of the reduced 1 trial assessing the tivus ... The TIVUSTM System is a novel ultrasound based device for renal denervation; we aim to present 12 month efficacy and safety endpoints from the pilot REDUCED 1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05372679

Renal Denervation Using Ultrasonic Catheter EmitteD ... The TIVUS™ System is a high intensity, non-focused, ultrasound catheter system, which enables remote, localized, controlled, and repeatable thermal modulation ...

3. clinicaltrials.cedars-sinai.edu clinicaltrials.cedars-sinai.edu/view/CLNS07001

Therapeutic Intravascular Ultrasound (TIVUS) Renal ... The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the TIVUS System to treat people who have hypertension.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06559891

Study Details | NCT06559891 | THRIVE- THerapeutic ... The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:.

5. recintervcardiol.org recintervcardiol.org/en/structural-intervention/efficacy-of-ultrasound-renal-denervation-reducing-blood-pressure-a-systematic-review-and-meta-analysis

Efficacy of ultrasound renal denervation reducing blood ... This meta-analysis includes data from 4 randomized controlled trials that evaluated the efficacy profile of uRDN in patients with true resistant hypertension ...

6. evtoday.com evtoday.com/news/sonivie-gains-ide-approval-for-thrive-pivotal-trial-of-tivus-rdn-system

SoniVie Gains IDE Approval for THRIVE Pivotal Trial of ... As summarized in the company's press release, the REDUCED-1 data showed an average -12.0 mmHg reduction in daytime ambulatory systolic blood ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12112698/

Renal Denervation After USA FDA Approval - PubMed Central Similarly, data from the RADIANCE-HTN TRIO trial demonstrated the safety and durability of ultrasound-based RDN, with a consistent reduction in systolic blood ...