Renal Denervation for Hypertension

Renown Regional Medical Center, Reno, NV
Hypertension+3 More ConditionsRenal Denervation - Device
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Resistant Hypertension
  • Cardiovascular Disease
  • Vascular Disease
  • High Blood Pressure

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure

Month 2
Change in average home systolic/diastolic BP
Change in average office systolic/diastolic BP
Month 6
Change in average daytime/24-hr/night-time ambulatory systolic BP
Month 2
Change in average 24-hr/night-time ambulatory systolic BP
Change in average daytime ambulatory systolic BP
Month 60
Incidence of Adverse Events
Month 2
Change in average 24-hr/night-time ambulatory diastolic BP

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Renal Denervation
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Renal Denervation · No Placebo Group · N/A

Renal Denervation
Device
Experimental Group · 1 Intervention: Renal Denervation · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Denervation
2013
Completed Early Phase 1
~250

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to months 2, 6, 12, 24, 36, 48, and 60 post procedure

Who is running the clinical trial?

ReCor Medical, Inc.Lead Sponsor
8 Previous Clinical Trials
3,836 Total Patients Enrolled
7 Trials studying Hypertension
3,761 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

Eligibility Criteria

Age 18 - 75 · All Participants · 0 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
The University of Texas Health Sciences Center at Houston100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "Help treat high blood pressure"
How many prior treatments have patients received?
1100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.