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Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension (REQUIRE)

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ClinicalTrials.gov Identifier: NCT02918305
Recruitment Status : Active, not recruiting
First Posted : September 28, 2016
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
JIMRO Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 27, 2016
First Posted Date  ICMJE September 28, 2016
Last Update Posted Date November 27, 2020
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
a decrease of average 24-hr ambulatory systolic BP from the baseline [ Time Frame: 3 month follow-up visit ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
  • a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively [ Time Frame: 3 month follow-up visit ]
  • a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively [ Time Frame: 3 month follow-up visit ]
  • a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline [ Time Frame: 3 month follow-up visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
Official Title  ICMJE A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
Brief Summary The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise® in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.
Detailed Description Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vascular Diseases
Intervention  ICMJE
  • Device: PRDS-001 Renal Denervation Ultrasound System
    Other Name: renal denervation
  • Procedure: Sham Procedure
    Other Name: renal angiography
Study Arms  ICMJE
  • Sham Comparator: PRDS-001 Renal Denervation Ultrasound System
    Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using PRDS-001 System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
    Intervention: Device: PRDS-001 Renal Denervation Ultrasound System
  • Sham Comparator: Sham Procedure
    Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.
    Intervention: Procedure: Sham Procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)
  • 24-hr ambulatory BP 140 mmHg or greater.

Exclusion Criteria:

  • Secondary hypertension (sleep apnoea can be included.)
  • Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater
  • Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)
  • eGFR<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)
  • Known severe cardiovascular events within 3 months or severe cerebrovascular events
  • Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months
  • Concurrent persistent atrial fibrillation
  • Patients those who are on active implantable medical devices
  • Primary pulmonary hypertension
  • Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918305
Other Study ID Numbers  ICMJE RDN-15-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JIMRO Co., Ltd.
Study Sponsor  ICMJE JIMRO Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account JIMRO Co., Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP