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History of Changes for Study: NCT02918305
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension (REQUIRE)
Latest version (submitted November 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 27, 2016 None (earliest Version on record)
2 September 29, 2017 Study Status, Contacts/Locations and Eligibility
3 July 17, 2018 Study Status and Contacts/Locations
4 August 7, 2018 Study Status and Contacts/Locations
5 May 23, 2019 Contacts/Locations and Study Status
6 February 18, 2020 Study Status and Contacts/Locations
7 November 25, 2020 Recruitment Status, Study Status and Contacts/Locations
8 August 26, 2021 Study Status
9 November 11, 2021 Recruitment Status, Study Status and Study Description
Comparison Format:

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Study NCT02918305
Submitted Date:  September 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: RDN-15-001
Brief Title: Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension (REQUIRE)
Official Title: A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2016
Overall Status: Recruiting
Study Start: June 2016
Primary Completion: December 2018 [Anticipated]
Study Completion: December 2019 [Anticipated]
First Submitted: September 27, 2016
First Submitted that
Met QC Criteria:
September 27, 2016
First Posted: September 28, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 27, 2016
Last Update Posted: September 28, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: JIMRO Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Hypertension
Vascular Diseases
Keywords: denervation
resistant hypertension
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 140 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Device: PRDS-001 Renal Denervation Ultrasound System
Other Names:
  • renal denervation
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.
Procedure: Sham Procedure
Other Names:
  • renal angiography
Open or close this module Outcome Measures
Primary Outcome Measures:
1. a decrease of average 24-hr ambulatory systolic BP from the baseline
[ Time Frame: 3 month follow-up visit ]

Secondary Outcome Measures:
1. 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 ]

2. 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 ]

3. 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 ]

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • average office systolic BP of 150 mmHg or greater and 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
Open or close this module Contacts/Locations
Central Contact Person: Yoshimi Tsuchimoto, Otsuka RDN Project
Telephone: 81334699351
Email: clinical-rdn@jimro.co.jp
Locations: Japan, Hokkaido
[Recruiting]
Sapporo, Hokkaido, Japan
Japan, Iwate
[Recruiting]
Morioka, Iwate, Japan
Japan, Osaka
[Recruiting]
Kishiwada, Osaka, Japan
[Recruiting]
Suita, Osaka, Japan
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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