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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 : Recruiting
First Posted : September 28, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
JIMRO Co., Ltd.

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
Hypertension Vascular Diseases 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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: renal angiography




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 ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918305


Contacts
Contact: Yoshimi Tsuchimoto, Otsuka RDN Project 81334699351 jimro-clinical-rdn@otsuka.jp

Locations
Japan
Recruiting
Hirosaki, Aomori, Japan
Recruiting
Toon, Ehime, Japan
Recruiting
Chikushino, Fukuoka, Japan
Recruiting
Kasuga, Fukuoka, Japan
Recruiting
Kitakyushu, Fukuoka, Japan
Recruiting
Kurume, Fukuoka, Japan
Recruiting
Seki, Gifu, Japan
Recruiting
Sapporo, Hokkaido, Japan
Recruiting
Tomakomai, Hokkaido, Japan
Recruiting
Amagasaki, Hyogo, Japan
Recruiting
Kobe, Hyogo, Japan
Recruiting
Nishinomiya, Hyogo, Japan
Recruiting
Morioka, Iwate, Japan
Recruiting
Yokohama, Kanagawa, Japan
Recruiting
Kahoku, Kanazawa, Japan
Recruiting
Kōchi, Kochi, Japan
Recruiting
Sendai, Miyagi, Japan
Recruiting
Nakagami, Okinawa, Japan
Recruiting
Kishiwada, Osaka, Japan
Recruiting
Suita, Osaka, Japan
Recruiting
Sayama, Saitama, Japan
Recruiting
Shimotsuke, Tochigi, Japan
Recruiting
Adachi, Tokyo, Japan
Recruiting
Chiyoda, Tokyo, Japan
Recruiting
Hachiōji, Tokyo, Japan
Recruiting
Meguro, Tokyo, Japan
Recruiting
Minato, Tokyo, Japan
Recruiting
Sakata, Yamagata, Japan
Recruiting
Fukuoka, Japan
Recruiting
Kumamoto, Japan
Recruiting
Kyoto, Japan
Recruiting
Miyazaki, Japan
Korea, Republic of
Not yet recruiting
Daegu, Korea, Republic of
Not yet recruiting
Daejeon, Korea, Republic of
Not yet recruiting
Gwangju, Korea, Republic of
Not yet recruiting
Gyeonggi‐do, Korea, Republic of
Recruiting
Incheon, Korea, Republic of
Not yet recruiting
Pusan, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
JIMRO Co., Ltd.

Responsible Party: JIMRO Co., Ltd.
ClinicalTrials.gov Identifier: NCT02918305     History of Changes
Other Study ID Numbers: RDN-15-001
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by JIMRO Co., Ltd.:
denervation
resistant hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases