What side effects are associated with this type of intervention?

Renal denervation therapy, which disrupts renal nerves to lower blood pressure, generally has few complications but can include procedural risks like vascular complications, bleeding, and rare renal artery damage. Other common antihypertensive treatments, such as ACE inhibitors, ARBs, and calcium channel blockers, may cause side effects like cough, hyperkalemia, dizziness, and edema. Beta-blockers can lead to fatigue, cold extremities, and bradycardia, while diuretics may result in electrolyte imbalances and dehydration.

What prior FDA approvals exist?

The FDA has approved several treatments for hypertension, including angiotensin-converting enzyme (ACE) inhibitors like enalapril and benazepril, angiotensin II receptor blockers (ARBs) such as valsartan, and calcium channel blockers like amlodipine. These medications primarily work by relaxing blood vessels and reducing blood pressure. While traditional pharmacological treatments are well-established, newer approaches like Ultrasound Renal Denervation Therapy, which involves disrupting renal nerves to lower blood pressure, are still under investigation. This innovative method aims to provide an alternative for patients with resistant hypertension who do not respond adequately to conventional medications.

What other types of research exist?

Promising novel alternatives to Ultrasound Renal Denervation Therapy for hypertension patients in 2024 include: 1) New classes of antihypertensive drugs such as dual-acting angiotensin receptor-neprilysin inhibitors (ARNIs) which have shown efficacy in lowering blood pressure. 2) Non-invasive neuromodulation techniques like baroreflex activation therapy, which targets the baroreceptors to regulate blood pressure. 3) Advanced combination therapies that utilize multiple antihypertensive agents in a single pill to improve adherence and efficacy. 4) Personalized medicine approaches using genetic and biomarker profiling to tailor antihypertensive therapy to individual patient needs. These alternatives offer potential benefits in terms of efficacy, safety, and patient compliance.

← 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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment that uses ultrasound waves to target kidney nerves to help lower blood pressure. It is aimed at patients whose high blood pressure does not improve with standard medications. The goal is to see if this method is safe and effective for these patients.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

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?