Renal Denervation for High Blood Pressure

(RADIANCE-II Trial)

Not currently recruiting at 59 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether the Paradise Renal Denervation System, a medical device, can safely and effectively lower high blood pressure in individuals with Stage 2 hypertension. The trial includes two groups: one will receive the actual treatment, while the other will undergo a sham procedure for comparison. It seeks participants with high blood pressure who use up to two medications and have remained stable without medication for four weeks. This trial suits those who have tried medications but still struggle with high blood pressure. As an unphased trial, it offers a unique opportunity for patients to contribute to groundbreaking research in hypertension treatment.

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

Research has shown that the Paradise Renal Denervation System is safe, as demonstrated in previous studies. In these trials, patients who received the treatment experienced a noticeable drop in blood pressure, indicating that the system effectively targets and alters the kidney nerves responsible for high blood pressure.

Further studies, some lasting up to nine years, have found the treatment to be well-tolerated with no major safety issues. The FDA has approved the system for treating high blood pressure in certain situations, confirming it meets safety standards for this condition.

Overall, the Paradise System appears to be a promising option for lowering high blood pressure, with a good safety record reported in research so far. ^{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 fluid volume. But the Paradise Renal Denervation System offers a different approach by using ultrasound energy to target overactive nerves in the kidneys that can contribute to high blood pressure. This method is unique because it directly interrupts the nerve signals that can raise blood pressure, potentially providing a long-lasting solution without daily pills. Researchers are excited about this treatment as it might offer a more consistent and sustained blood pressure reduction, especially for patients who don't respond well to medications.

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

Research has shown that the Paradise Renal Denervation System, which participants in this trial may receive, can effectively lower blood pressure. One study reduced blood pressure by 19.6 mmHg after six months. Another study found that patients who received the treatment had a 4.5 mmHg lower systolic blood pressure (the top number in a blood pressure reading) compared to those who did not receive it. The system uses ultrasound energy to target nerves in the kidneys, helping to lower blood pressure. This trial will compare the Paradise Renal Denervation System with a Sham Control, which involves a renal angiogram without the denervation procedure. The FDA has already approved the Paradise Renal Denervation System for people with high blood pressure. ^{1 2 4 5 6}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

I have not had a stroke, severe heart event, or chest pain in the last year.

I've been hospitalized more than once for high blood pressure crises in the last year.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000240

Renal Denervation for the Treatment of Hypertension The Paradise System was also shown to be effective in reducing SBP in the RADIANCE HTN TRIO trial, with a between-group difference of −4.5 ...

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 ... Similar to the OFF-MED trial, office and 24-hr ambulatory BP decreased significantly in the renal denervation group (difference of −6.8 mmHg, 95% CI: −12.5 to − ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39787346/

The Paradise Renal Denervation System: An FDA ... The RADIANCE trials have demonstrated that patients who underwent renal denervation had a significant decrease in systolic blood pressure as ...