Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Radiance High Blood Pressure Study

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System can safely reduce high blood pressure in patients who are known to have hypertension.

Brigham and Women's Hospital Blood Pressure Medicines High Blood Pressure
13 visits
Estimated Time Commitment
Any Sex/Gender, 18-75 years
May Be Eligible
Payment up to $1,000
May Be Offered
Blood draw, Medication, Ultrasound, Office visit, CT scan, Surgical procedure, Sedation
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

The study is designed to evaluate a minimally invasive procedure to reduce blood pressure, using ultrasound technology to treat overactive nerves which travel to the kidney. The study objective is to evaluate if the procedure will reduce your high blood pressure and whether the amount of medication you take to control your hypertension can be reduced. 


Why it is important

Worldwide there are over 1 billion people with hypertension and this number is expected to grow. Hypertension can be very dangerous to your health and has been shown to increase the risk of heart disease, kidney disease, vascular disease and stroke. Clinical research studies are an important step that may help us understand how to manage hypertension.


What we hope to accomplish

The study hopes to determine whether the Paradise Renal Denervation System can safely and effectively reduce high blood pressure

Principal Investigator

Naomi Fisher, MD

Brigham and Women's Hospital

Public Profile

Who can participate

 


Two study cohorts will be evaluated:



  • RADIANCE Solo cohort: Subjects with essential hypertension controlled on 1 or 2 blood pressure medications or uncontrolled on 0-2 blood pressure medications



  • RADIANCE Trio cohort: Subjects with treatment resistant hypertension on a minimum of 3 blood pressure medications


To see if you may qualify for the study, please complete the following pre-screen survey:


https://is.gd/bwhBPtrial

What you may be asked to do


  • Daily blood pressure measurements

  • Suspend or switch blood pressure medications for up to 3 months

  • 24-hour ambulatory blood pressure measurement

  • Have an ECG to measure heart activity

  • Provide urine and blood samples

  • Have an ultrasound of your renal arteries

  • Have a CT angiogram to take pictures of your kidneys

  • Undergo study procedure: renal angiogram or renal angiogram and renal denervation


Project activities may include:

  • Blood draw
  • Medication
  • Ultrasound
  • Office visit
  • CT scan
  • Surgical procedure
  • Sedation

Estimated Time Commitment

13 visits

What You May Get

reimbursement for travel expenses. $80-$100 at most visits.

Location


221 Longwood Ave, Boston, MA 02115

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Travel

  • Travel reimbursed
  • Local travel reimbursed
  • Accessible by public transportation

Travel and Parking Details

Additional Information

Project Website

http://bwhbpstudy.com/


ClinicalTrials.gov Identifier

NCT02649426


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • Industry
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