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Renal Denervation for High Blood Pressure (RADIANCE CAP Trial)

N/A
Waitlist Available
Led By Ajay Kirtane, MD, SM
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure
Awards & highlights

RADIANCE CAP Trial 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.

RADIANCE CAP Trial 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

RADIANCE CAP 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

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
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
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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join the research cohort?

"To partake in this research, potential participants must have cardiovascular diseases and be aged between 18-75 years. According to the study, 300 individuals need to enrol."

Answered by AI

Are there opportunities for new participants to join this research endeavor?

"This medical experiment is actively recruiting, as evidenced by recent updates to the clinicaltrials.gov page which notes that it was first posted on May 4th 2022 and last modified November 23rd of this year."

Answered by AI

Does this research encompass those who are under thirty years of age?

"This trial only admits participants aged 18 to 75. For those who are underaged, there are 82 clinical trials that may be suitable and for seniors (over 65), 1059 medical studies might provide the necessary treatment."

Answered by AI

How many participants are included in this experiment?

"In order to conduct the trial, 300 participants that meet the inclusion criteria need to be recruited. ReCor Medical Inc., is overseeing this experiment across multiple sites including The Brigham and Women's Hospital in Massachusetts and Medical University of South carolina in Charleston."

Answered by AI

Is this medical trial being conducted extensively in Canadian hospitals?

"This medical study is being conducted in The Brigham and Women's Hospital, Medical University of South carolina, Swedish Health Services as well as 12 other sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Texas
What site did they apply to?
Henry Ford Hospital
University of Texas Health Sciences Center, San Antonio
The University of Texas Health Sciences Center at Houston
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Help treat high blood pressure.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Henry Ford Hospital: < 48 hours
Average response time
  • < 2 Days
~200 spots leftby Dec 2028