Renal Denervation for High Blood Pressure (RADIANCE-HTN Trial)

N/A

Waitlist Available

Led By Michel Azizi, MD, PhD

Research Sponsored by ReCor Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented history of essential hypertension

TRIO Cohort: Meeting specific blood pressure criteria while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 6, 12, 24 and 36 months post-procedure

Summary

This trial is designed to study whether a new renal denervation system is effective and safe in two groups of people with hypertension.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects are not listed here, procedures like renal denervation could potentially cause discomfort, bruising or bleeding at the access site, reactions to contrast media used in imaging, or rare complications related to catheter-based interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with high blood pressure.

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I am on 3 different blood pressure medicines including a diuretic and my blood pressure meets specific criteria.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6, 12, 24 and 36 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 6, 12, 24 and 36 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6, 12, 24 and 36 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP

Trio Cohort - Median Change in Daytime Ambulatory Systolic BP

Secondary study objectives

Significant (>50%) and Severe (>75%) New Onset Renal Stenosis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ultrasound Renal DenervationExperimental Treatment1 Intervention

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

Group II: Sham ProcedurePlacebo Group1 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.

0 / 3Eligibility criteria met