Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
NCT ID: NCT02918305
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2017-01-31
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
PRDS-001 Renal Denervation Ultrasound System
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.
Sham Procedure
Interventions
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PRDS-001 Renal Denervation Ultrasound System
Sham Procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 24-hr ambulatory BP 140 mmHg or greater.
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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JIMRO Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hirosaki, Aomori, Japan
Urayasu, Chiba, Japan
Tōon, Ehime, Japan
Chikushino-shi, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Sekimachi, Gifu, Japan
Nayoro, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Tomakomai, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Kanazawa, Ishikawa-ken, Japan
Morioka, Iwate, Japan
Yokohama, Kanagawa, Japan
Kahoku, Kanazawa, Japan
Kōchi, Kochi, Japan
Suzuka, Mie-ken, Japan
Sendai, Miyagi, Japan
Nakagami, Okinawa, Japan
Kishiwada, Osaka, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Sayama, Saitama, Japan
Shimotsuke, Tochigi, Japan
Adachi City, Tokyo, Japan
Chiyoda City, Tokyo, Japan
Hachiōji, Tokyo, Japan
Meguro City, Tokyo, Japan
Minato, Tokyo, Japan
Minato-Ku, Tokyo, Japan
Musashino, Tokyo, Japan
Sakata, Yamagata, Japan
Fukuoka, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Miyazaki, , Japan
Niigata, , Japan
Okayama, , Japan
Saga, , Japan
Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gangneung, , South Korea
Gwangju, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Yangsan, , South Korea
Countries
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References
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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.
Other Identifiers
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RDN-15-001
Identifier Type: -
Identifier Source: org_study_id