← Back to Search

Renal Denervation for High Blood Pressure (RADIANCE CAP Trial)

N/A
Waitlist Available
Led By Naomi Fisher, MD
Research Sponsored by ReCor Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Renal artery anatomy ineligible for treatment
Secondary hypertension not including sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure
Awards & highlights

Summary

This trial will allow people who haven't been helped by other medications to keep using a therapy that uses sound waves to target the nerves around the kidney.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, renal denervation procedures may cause discomfort at the site of intervention, bleeding, bruising, potential damage to the renal artery, changes in blood pressure levels, and possible impacts on kidney function.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney's blood vessels are not suitable for treatment.
Select...
I have high blood pressure caused by another health condition, not sleep apnea.
Select...
I have high blood pressure in the lungs.
Select...
I need oxygen or a ventilator during the day, not just for sleep apnea at night.
Select...
I have been hospitalized more than once for high blood pressure crises in the last 3 months.
Select...
I have Type I diabetes or my Type II diabetes is not under control (HbA1c ≥9.0%).
Select...
I have had episodes of severe chest pain in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in average daytime ambulatory systolic BP
Incidence of Adverse Events
Secondary outcome measures
Change in average 24-hr/night-time ambulatory diastolic BP
Change in average 24-hr/night-time ambulatory systolic BP
Change in average daytime/24-hr/night-time ambulatory systolic BP
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Renal DenervationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Denervation
2013
Completed Early Phase 1
~360

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for hypertension include angiotensin receptor blockers (ARBs), ACE inhibitors, and renal denervation therapy. ARBs and ACE inhibitors work by interfering with the renin-angiotensin-aldosterone system (RAAS), which regulates blood pressure and fluid balance. ARBs block the angiotensin II receptors, preventing vasoconstriction and reducing blood pressure, while ACE inhibitors prevent the formation of angiotensin II, leading to similar effects. Renal denervation therapy, such as ultrasound renal denervation, disrupts the renal nerves, which play a role in blood pressure regulation by modulating sympathetic nervous system activity. This disruption can lead to a sustained reduction in blood pressure. These treatments are crucial for hypertension patients as they help manage blood pressure levels, reducing the risk of cardiovascular events and kidney damage.
Renal denervation: can we press the "ON" button again in 2020?

Find a Location

Who is running the clinical trial?

ReCor Medical, Inc.Lead Sponsor
10 Previous Clinical Trials
4,876 Total Patients Enrolled
9 Trials studying Hypertension
4,801 Patients Enrolled for Hypertension
Naomi Fisher, MDPrincipal InvestigatorBrigham and Women's Hospital/Harvard Medical School
2 Previous Clinical Trials
80 Total Patients Enrolled
2 Trials studying Hypertension
80 Patients Enrolled for Hypertension
Ajay Kirtane, MD, SMPrincipal InvestigatorColumbia University Medical Center/NYPH
2 Previous Clinical Trials
2,230 Total Patients Enrolled
1 Trials studying Hypertension
225 Patients Enrolled for Hypertension

Media Library

Renal Denervation Clinical Trial Eligibility Overview. Trial Name: NCT05017935 — N/A
Hypertension Research Study Groups: Renal Denervation
Hypertension Clinical Trial 2023: Renal Denervation Highlights & Side Effects. Trial Name: NCT05017935 — N/A
Renal Denervation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017935 — N/A
Hypertension Patient Testimony for trial: Trial Name: NCT05017935 — N/A
~200 spots leftby Dec 2028