25 Participants Needed

Renal Denervation for High Blood Pressure

(REDUCED Trial)

Recruiting at 8 trial locations
CS
JJ
JG
AP
AK
Overseen ByAjay Kirtane, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: SoniVie Inc.
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System in subjects with uncontrolled stage 2 hypertension in order to assess the safety and effectiveness of the TIVUS™ System when used for renal artery denervation. The study will assess the acute and chronic safety of the procedure as well as the reduction in 24-hour ambulatory mean systolic blood pressure from baseline to 3 months after the procedure.

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 data supports the effectiveness of the TIVUS™ System treatment for high blood pressure?

Research on renal denervation, a treatment that uses energy to disrupt nerves in the kidneys, shows it can lower blood pressure in patients with resistant hypertension (high blood pressure that doesn't respond to medication). Studies like the DENERHTN trial and others have confirmed its effectiveness when combined with other treatments.12345

Is renal denervation safe for humans?

Studies on renal denervation, including those using different systems like radiofrequency and balloon catheters, have been conducted to assess safety. While some trials report limited long-term safety data, others focus on evaluating adverse events related to the procedure, indicating ongoing research to ensure its safety in humans.26789

How does the TIVUS™ System treatment for high blood pressure differ from other treatments?

The TIVUS™ System is unique because it uses ultrasound energy to target the renal nerves, which may help lower blood pressure by disrupting nerve signals that contribute to hypertension. This approach is different from traditional drug therapies and other renal denervation systems that typically use radiofrequency energy.36101112

Research Team

Ajay J. Kirtane, MD, Cardiovascular ...

Ajay Kirtane, MD

Principal Investigator

Columbia University/NYPH

Eligibility Criteria

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.
See 9 more

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.
See 32 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Renal denervationExperimental Treatment1 Intervention
Denervating the sympathetic nerves surrounding the renal vasculature using unfocused ultrasound

Find a Clinic Near You

Who Is Running the Clinical Trial?

SoniVie Inc.

Lead Sponsor

Trials
6
Recruited
540+

Findings from Research

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

References

Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. [2017]
Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. [2022]
Safety and performance of the second generation EnligHTN™ Renal Denervation System in patients with drug-resistant, uncontrolled hypertension. [2022]
Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. [2023]
Current Status of Renal Denervation in Hypertension. [2018]
The rise, fall, and possible resurrection of renal denervation. [2018]
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. [2022]
Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation. [2021]
Safety and Efficacy of a New Renal Denervation Catheter in Hypertensive Patients in the Absent of Antihypertensive Medications: A Pilot Study. [2022]
Italian Society of Arterial Hypertension (SIIA) Position Paper on the Role of Renal Denervation in the Management of the Difficult-to-Treat Hypertensive Patient. [2020]
Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension. [2022]
12.Korea (South)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. [2021]
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