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

Primary Purpose

Hypertension, Vascular Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PRDS-001 Renal Denervation Ultrasound System
Sham Procedure
Sponsored by
JIMRO Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring denervation, resistant hypertension

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Sham Comparator

Arm Label

PRDS-001 Renal Denervation Ultrasound System

Sham Procedure

Arm Description

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.

Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.

Outcomes

Primary Outcome Measures

a decrease of average 24-hr ambulatory systolic BP from the baseline

Secondary Outcome Measures

a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively
a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively
a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline

Full Information

First Posted
September 27, 2016
Last Updated
November 11, 2021
Sponsor
JIMRO Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02918305
Brief Title
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
Acronym
REQUIRE
Official Title
A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
October 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JIMRO Co., Ltd.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases
Keywords
denervation, resistant hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PRDS-001 Renal Denervation Ultrasound System
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
PRDS-001 Renal Denervation Ultrasound System
Other Intervention Name(s)
renal denervation
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Other Intervention Name(s)
renal angiography
Primary Outcome Measure Information:
Title
a decrease of average 24-hr ambulatory systolic BP from the baseline
Time Frame
3 month follow-up visit
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Hirosaki
State/Province
Aomori
Country
Japan
City
Urayasu
State/Province
Chiba
Country
Japan
City
Toon
State/Province
Ehime
Country
Japan
City
Chikushino
State/Province
Fukuoka
Country
Japan
City
Kasuga
State/Province
Fukuoka
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Seki
State/Province
Gifu
Country
Japan
City
Nayoro
State/Province
Hokkaido
Country
Japan
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Tomakomai
State/Province
Hokkaido
Country
Japan
City
Amagasaki
State/Province
Hyogo
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Nishinomiya
State/Province
Hyogo
Country
Japan
City
Kanazawa
State/Province
Ishikawa
Country
Japan
City
Morioka
State/Province
Iwate
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Kahoku
State/Province
Kanazawa
Country
Japan
City
Kōchi
State/Province
Kochi
Country
Japan
City
Suzuka
State/Province
Mie
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Nakagami
State/Province
Okinawa
Country
Japan
City
Kishiwada
State/Province
Osaka
Country
Japan
City
Sakai
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Sayama
State/Province
Saitama
Country
Japan
City
Shimotsuke
State/Province
Tochigi
Country
Japan
City
Adachi
State/Province
Tokyo
Country
Japan
City
Chiyoda
State/Province
Tokyo
Country
Japan
City
Hachiōji
State/Province
Tokyo
Country
Japan
City
Meguro
State/Province
Tokyo
Country
Japan
City
Minato-Ku
State/Province
Tokyo
Country
Japan
City
Minato
State/Province
Tokyo
Country
Japan
City
Musashino
State/Province
Tokyo
Country
Japan
City
Sakata
State/Province
Yamagata
Country
Japan
City
Fukuoka
Country
Japan
City
Hiroshima
Country
Japan
City
Kagoshima
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki
Country
Japan
City
Niigata
Country
Japan
City
Okayama
Country
Japan
City
Saga
Country
Japan
City
Busan
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gangneung
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Gyeonggi-do
Country
Korea, Republic of
City
Incheon
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34654905
Citation
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.
Results Reference
derived

Learn more about this trial

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

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