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

• ClinicalTrials.gov Identifier: NCT02918305
• Recruitment Status: Completed
• First Posted: September 28, 2016
• Last Update Posted: November 19, 2021
• Sponsor: JIMRO Co., Ltd.
• Information provided by (Responsible Party): JIMRO Co., Ltd.

Tracking Information

• First Submitted Date: September 27, 2016
• First Posted Date: September 28, 2016
• Last Update Posted Date: November 19, 2021
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hypertension
• Vascular Diseases

Intervention

• Device: PRDS-001 Renal Denervation Ultrasound System
  Other Name: renal denervation
• Procedure: Sham Procedure
  Other Name: renal angiography

Study Arms

• 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 *: Kario K, Yokoi Y, Okamura K, Fujihara M, Ogoyama Y, Yamamoto E, Urata H, Cho JM, Kim CJ, Choi SH, Shinohara K, Mukai Y, Ikemoto T, Nakamura M, Seki S, Matoba S, Shibata Y, Sugawara S, Yumoto K, Tamura K, Yoshihara F, Nakamura S, Kang WC, Shibasaki T, Dote K, Yokoi H, Matsuo A, Fujita H, Takahashi T, Kang HJ, Sakata Y, Horie K, Inoue N, Sasaki KI, Ueno T, Tomita H, Morino Y, Nojima Y, Kim CJ, Matsumoto T, Kai H, Nanto S. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial. Hypertens Res. 2022 Feb;45(2):221-231. doi: 10.1038/s41440-021-00754-7. Epub 2021 Oct 15.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 27, 2016): 140
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2021
• Actual Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Korea, Republic of

Administrative Information

• NCT Number: NCT02918305
• Other Study ID Numbers: RDN-15-001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: JIMRO Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: JIMRO Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: JIMRO Co., Ltd.
• Verification Date: November 2021