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

Sponsor
JIMRO Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02918305
Collaborator
(none)
140
Enrollment
53
Locations
2
Arms
57
Actual Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: PRDS-001 Renal Denervation Ultrasound System
  • Procedure: Sham Procedure
 Phase 3

Detailed Description

Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. a decrease of average 24-hr ambulatory systolic BP from the baseline [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 [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 [3 month follow-up visit]

    3. a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline [3 month follow-up visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hirosaki Aomori Japan
    2 Urayasu Chiba Japan
    3 Toon Ehime Japan
    4 Chikushino Fukuoka Japan
    5 Kasuga Fukuoka Japan
    6 Kitakyushu Fukuoka Japan
    7 Kurume Fukuoka Japan
    8 Seki Gifu Japan
    9 Nayoro Hokkaido Japan
    10 Sapporo Hokkaido Japan
    11 Tomakomai Hokkaido Japan
    12 Amagasaki Hyogo Japan
    13 Kobe Hyogo Japan
    14 Nishinomiya Hyogo Japan
    15 Kanazawa Ishikawa Japan
    16 Morioka Iwate Japan
    17 Yokohama Kanagawa Japan
    18 Kahoku Kanazawa Japan
    19 Kōchi Kochi Japan
    20 Suzuka Mie Japan
    21 Sendai Miyagi Japan
    22 Nakagami Okinawa Japan
    23 Kishiwada Osaka Japan
    24 Sakai Osaka Japan
    25 Suita Osaka Japan
    26 Sayama Saitama Japan
    27 Shimotsuke Tochigi Japan
    28 Adachi Tokyo Japan
    29 Chiyoda Tokyo Japan
    30 Hachiōji Tokyo Japan
    31 Meguro Tokyo Japan
    32 Minato-Ku Tokyo Japan
    33 Minato Tokyo Japan
    34 Musashino Tokyo Japan
    35 Sakata Yamagata Japan
    36 Fukuoka Japan
    37 Hiroshima Japan
    38 Kagoshima Japan
    39 Kumamoto Japan
    40 Kyoto Japan
    41 Miyazaki Japan
    42 Niigata Japan
    43 Okayama Japan
    44 Saga Japan
    45 Busan Korea, Republic of
    46 Daegu Korea, Republic of
    47 Daejeon Korea, Republic of
    48 Gangneung Korea, Republic of
    49 Gwangju Korea, Republic of
    50 Gyeonggi-do Korea, Republic of
    51 Incheon Korea, Republic of
    52 Seoul Korea, Republic of
    53 Yangsan Korea, Republic of

    Sponsors and Collaborators

    • JIMRO Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JIMRO Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02918305
    Other Study ID Numbers:
    • RDN-15-001
    First Posted:
    Sep 28, 2016
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by JIMRO Co., Ltd.
    denervation
    resistant hypertension
    Additional relevant MeSH terms:
    Hypertension
    Vascular Diseases

    Study Results

    No Results Posted as of Nov 19, 2021