Renal Denervation for High Blood Pressure

(RADIANCE-II Trial)

Recruiting at 57 trial locations

Overseen By Ajay J Kirtane, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReCor Medical, Inc.

Disqualifiers: Diabetes, Cardiovascular events, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6-8 weeks

225 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.

Will I have to stop taking my current medications?

Yes, participants will need to stop taking their current hypertension medications for a 4-week period before randomization.

What data supports the effectiveness of the Paradise Renal Denervation System treatment for high blood pressure?

Research shows that the Paradise Renal Denervation System, which uses ultrasound to target nerves in the kidneys, has shown promising results in lowering blood pressure in patients with hypertension (high blood pressure). Studies have demonstrated its effectiveness and safety, and ongoing trials are expected to provide further confirmation. ^{1 2 3 4 5}

How is the Paradise Renal Denervation System treatment different from other treatments for high blood pressure?

The Paradise Renal Denervation System is unique because it uses ultrasound energy delivered through a catheter to target and disrupt the nerves in the kidneys that contribute to high blood pressure, while a balloon cools the area to protect the artery walls. This non-drug, device-based approach offers an alternative for patients who may not respond well to traditional blood pressure medications. ^{1 2 4 5 6}

Research Team

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation

Prof. Michel Azizi, MD, PhD

Principal Investigator

Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou

Eligibility Criteria

This trial is for adults with Stage II hypertension, who have been on 0-2 blood pressure medications. They should have a documented high blood pressure range and can't be on chronic oxygen support or have severe cardiovascular issues. Pregnant individuals or those with uncontrolled diabetes are excluded.

Inclusion Criteria

My blood pressure is between 135/85 and 170/105 mmHg after a 4-week period without medication.

My blood pressure is between 140/90 and 179/119 mmHg, and I've been stable on up to 2 blood pressure medications for at least 4 weeks.

I have been prescribed medication for high blood pressure.

Exclusion Criteria

I have high blood pressure in the lungs.

Night shift workers

Pregnant, nursing or planning to become pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo renal angiogram and renal denervation using the Paradise Renal Denervation System or a sham procedure

6-8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

Treatment Details

Interventions

• Paradise Renal Denervation System
• Renal Angiogram

Trial Overview The study tests the Paradise System's safety and effectiveness in lowering blood pressure compared to a renal angiogram procedure. Participants will either receive the Paradise treatment or undergo an angiogram without denervation.

Participant Groups

Group I: Renal Denervation Experimental Treatment 1 Intervention

Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)

Group II: Sham Control Placebo Group 1 Intervention

Renal Angiogram

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials

11

Recruited

5,200+

Findings from Research

The Global Paradise™ System (GPS) registry aims to evaluate the long-term safety and effectiveness of ultrasound renal denervation (uRDN) in up to 3000 patients with hypertension over a 5-year follow-up period, providing valuable real-world data.

By focusing on standardized home blood pressure measurements and patient-reported outcomes, the study seeks to enhance understanding of uRDN's impact on blood pressure control and quality of life in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design. Mahfoud, F., Azizi, M., Daemen, J., et al.[2023]

References

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

Real-world experience with ultrasound renal denervation utilizing home blood pressure monitoring: the Global Paradise System registry study design. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Controlled circumferential renal sympathetic denervation with preservation of the renal arterial wall using intraluminal ultrasound: a next-generation approach for treating sympathetic overactivity. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Effect of renal denervation on long-term outcomes in patients with resistant hypertension. [2022]

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

Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension. [2022]

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

Adherence to Antihypertensive Treatment and the Blood Pressure-Lowering Effects of Renal Denervation in the Renal Denervation for Hypertension (DENERHTN) Trial. [2017]

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

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs. [2017]