Renal Denervation for High Blood Pressure

(RADIANCE-HTN Trial)

Not currently recruiting at 51 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReCor Medical, Inc.

Must be taking: Antihypertensives

Must not be taking: Beta blockers

Disqualifiers: Diabetes, Cardiovascular events, Renal issues, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of the Paradise Renal Denervation System, a treatment for high blood pressure. The study involves two groups: one will receive the actual treatment, while the other will undergo a sham procedure for comparison. The trial seeks participants with a history of high blood pressure that persists despite lifestyle changes and medication.

As an unphased trial, this study offers participants the chance to contribute to important research that could lead to new treatment options for high blood pressure.

Do I have to stop taking my current medications for the trial?

For the SOLO cohort, you may need to stop taking your antihypertensive medications for a 4-week period before the trial. For the TRIO cohort, you must continue your current regimen of at least 3 antihypertensive medications, including a diuretic, for at least 4 weeks before the trial.

What prior data suggests that the Paradise® Renal Denervation Ultrasound System is safe for treating high blood pressure?

Research has shown that the Paradise Renal Denervation Ultrasound System is generally safe for lowering high blood pressure. The FDA has approved this system for treating high blood pressure, and patients have received it well.

Past studies linked the system to significant drops in blood pressure without major safety issues. Reports of serious negative side effects are absent, indicating that most patients did not experience severe problems.

Overall, evidence suggests that the treatment is safe for most people. However, consulting a doctor is essential to determine if it's the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for high blood pressure involve medications like ACE inhibitors, beta-blockers, or diuretics, which work by relaxing blood vessels or reducing blood volume. But the Paradise® Renal Denervation Ultrasound System offers a different approach. It uses ultrasound energy to target and disrupt nerve activity in the renal arteries, which can help lower blood pressure without daily medication. This non-drug approach is exciting because it could provide a more lasting solution for patients, especially those who struggle with medication side effects or adherence. Researchers are particularly interested in its potential to offer a new, effective treatment for those with resistant hypertension.

What evidence suggests that the Paradise® Renal Denervation Ultrasound System is effective for high blood pressure?

Research has shown that the Paradise Renal Denervation Ultrasound System, which participants in this trial may receive, can help lower high blood pressure. In studies, patients experienced a significant drop in blood pressure, with one report noting a decrease of 19.6 mmHg after six months. This treatment uses ultrasound energy to target and disrupt the nerves around the kidneys that contribute to high blood pressure. Over time, this method has improved blood pressure control. The FDA has approved the system for treating high blood pressure, providing some confidence in its effectiveness. Participants in this trial may also be assigned to a sham procedure group for comparison. ^{1 2 3 4 5}

Who Is on the Research Team?

Ajay Kirtane, MD

Principal Investigator

Columbia University

Michel Azizi, MD, PhD

Principal Investigator

Hôpital Européen Georges-Pompidou

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with high blood pressure who can follow the study plan. Participants must have a history of hypertension and suitable renal anatomy. The SOLO group includes those on blood pressure meds or lifestyle changes, while the TRIO group requires being on at least three different blood pressure medications including a diuretic.

Inclusion Criteria

Your kidneys need to be in good shape for the procedure, as shown by a recent high-quality scan.

I have been diagnosed with high blood pressure.

My blood pressure meets specific criteria even though I'm on medication or have tried lifestyle changes.

Exclusion Criteria

My kidney condition fits specific medical criteria.

I have specific kidney or heart conditions or a history of certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the sham procedure or renal denervation treatment

2 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Multiple visits (in-person) at 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Sham Procedure
• The Paradise® Renal Denervation Ultrasound System

Trial Overview The study tests the Paradise Renal Denervation System against a sham (fake) procedure to see if it's effective and safe in lowering blood pressure. It has two parts: one for patients less dependent on medication (SOLO) and another for those needing multiple drugs (TRIO).

How Is the Trial Designed?

Group I: Ultrasound Renal Denervation Experimental Treatment 1 Intervention

Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram

Group II: Sham Procedure Placebo Group 1 Intervention

For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials

11

Recruited

5,200+

Citations

1. recormedical.com recormedical.com/latest-real-world-clinical-data-demonstrate-a-19-6-mmhg-reduction-in-blood-pressure-at-6-months-with-recor-medicals-paradise-ultrasound-renal-denervation-system/

Latest Real-World Clinical Data Demonstrate a 19.6 mmHg ... Latest Real-World Clinical Data Demonstrate a 19.6 mmHg Reduction in Blood Pressure at 6 Months with Recor Medical's Paradise Ultrasound Renal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06297291

Global Paradise System US Post Approval Study The Paradise Ultrasound Renal Denervation System (Paradise Ultrasound RDN) is an FDA-approved catheter-based system to treat hypertension by ablating the nerves ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220023B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Paradise Ultrasound Renal Denervation System (Paradise System) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6186633/

Renal denervation with ultrasound therapy (paradise ... The extent of BP reduction with renal denervation increased over the follow-up period to 6 months (8). In The Lancet, Azizi et al. reported the results of the ...

5. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2018/05/24/12/10/RADIANCE-HTN-SOLO

A Study of the ReCor Medical Paradise System in Clinical ... Renal denervation with the Paradise endovascular ultrasound renal denervation system resulted in a greater reduction in both SBP and DBP at 2 months compared ...