Renal Denervation for High Blood Pressure

(RADIANCE CAP Trial)

Not currently recruiting at 39 trial locations

Overseen By Konstantinos Charitakis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ReCor Medical, Inc.

Must be taking: Antihypertensives

Disqualifiers: Type I diabetes, Uncontrolled Type II diabetes, Severe cardiovascular event, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Paradise System for individuals with high blood pressure not controlled by medication. The main goal is to determine if this treatment, which uses ultrasound on the kidneys, is safe and effective. It targets those with high blood pressure readings of at least 140/90 mmHg despite taking prescribed medications for at least four weeks. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatment options for high blood pressure.

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

The trial does not specify that you need to stop taking your current medications. In fact, it requires that you have been on stable doses of antihypertensive medications for at least 4 weeks before joining.

What prior data suggests that this renal denervation technique is safe for high blood pressure?

Research has shown that the Paradise System, used for ultrasound renal denervation in kidney treatment, is generally safe. Studies reported no cases of renal artery stenosis or deaths within 30 days post-procedure. This suggests that most people tolerate the treatment well. The system has been used for several years in patients with high blood pressure, consistently demonstrating safe results. Although risks exist, the evidence so far indicates a reassuring safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Renal denervation is unique because it targets the overactive nerves in the kidneys that can contribute to high blood pressure. Unlike standard treatments like medication that work by relaxing blood vessels or reducing blood volume, this technique uses a minimally invasive procedure to disrupt these nerves directly. Researchers are excited because it offers a new way to potentially control blood pressure for people who don't respond well to traditional medications, providing hope for a more effective long-term solution.

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

Research has shown that the Paradise System for renal denervation, which participants in this trial will receive, effectively lowers blood pressure. Studies have found that blood pressure can drop significantly just two months after treatment. Long-term data over nine years confirm its safety and continued effectiveness for patients with resistant hypertension, which is high blood pressure that doesn't respond well to medication. The system uses ultrasound to target nerves in the kidneys, helping to lower blood pressure. It offers a promising option for those whose blood pressure remains high despite medication. ^{1 2 5 6 7}

Who Is on the Research Team?

Ajay Kirtane, MD

Principal Investigator

Columbia University Medical Center/NYPH

Naomi Fisher, MD

Principal Investigator

Brigham and Women's Hospital/Harvard Medical School

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure that remains uncontrolled despite taking medication. Participants must have a documented average office blood pressure of at least 140/90 mmHg and daytime ambulatory blood pressure of at least 135/85 mmHg. They should not have had severe cardiovascular events or strokes in the past three months, be pregnant, or have certain conditions like Type I diabetes or severely impaired kidney function.

Inclusion Criteria

My blood pressure is 140/90 or higher, even though I've been on blood pressure medicine for over 4 weeks.

My daytime blood pressure is 135/85 mmHg or higher, even after 4 weeks on blood pressure medication.

Exclusion Criteria

Pregnant, nursing or planning to become pregnant

My kidney's blood vessels are not suitable for treatment.

I haven't had a stroke or major heart issue 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 receive ultrasound renal denervation therapy via the Paradise System

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paradise System

Trial Overview The RADIANCE CAP study is testing ultrasound renal denervation therapy using the Paradise System to treat uncontrolled hypertension. It's an ongoing non-randomized trial providing access to this treatment while collecting data on its safety and effectiveness.

How Is the Trial Designed?

Group I: Renal Denervation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

ReCor Medical, Inc.

Lead Sponsor

Trials

11

Recruited

5,200+

Citations

1. recormedical.com recormedical.com/clinical-results-highlights/

Clinical Results Highlights Demonstrated effectiveness in lowering blood pressure at two months and beyond. The Paradise Ultrasound RDN system met the primary blood pressure reduction ...

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

Renal Denervation for the Treatment of Hypertension Catheter-based renal denervation: 9-year follow-up data on safety and blood pressure reduction in patients with resistant hypertension.

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The probable benefits of the Paradise System include a reduction in blood pressure in adult patients with hypertension. The probable risks of the device ...

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

Renal denervation with ultrasound therapy (paradise ... Recently, Townsend et al. reported 3 months results of the SPYRAL HTN OFF-MED trial, that demonstrated a significant reduction in 24-hr ambulatory BP in ...

5. nature.com nature.com/articles/s41440-024-01667-x

Outcome data for renal denervation - hypertension research Additionally, data from three trials conducted in China provide further evidence supporting the BP-lowering efficacy of radiofrequency RDN using ...

6. acc.org acc.org/Latest-in-Cardiology/Articles/2024/10/08/17/47/Safety-and-Efficacy-of-Renal-Denervation-in-Patients-With-HTN

Safety and Efficacy of Renal Denervation in Patients With ... Renal artery stenosis and all-cause 30-day death rates were 0%. The RADIANCE II data demonstrated the benefit of ultrasound-based RDN therapy in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11139244/

Renal denervation for uncontrolled hypertension This meta-analysis suggests that the use of RDN in uncontrolled hypertension leads to consistent reductions in blood pressure.