Clinical trial NCT02918305: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Vascular Diseases
Keywords: denervation
resistant hypertension
Lead sponsor: JIMRO Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: a decrease of average 24-hr ambulatory systolic BP from the baseline
timeFrame: 3 month follow-up visit
Secondary outcomes:
measure: a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively
timeFrame: 3 month follow-up visit
measure: a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively
timeFrame: 3 month follow-up visit
measure: a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline
timeFrame: 3 month follow-up visit
Other outcomes:
Locations:
city: Hirosaki
country: Japan
state: Aomori
city: Urayasu
country: Japan
state: Chiba
city: Toon
country: Japan
state: Ehime
city: Chikushino
country: Japan
state: Fukuoka
city: Kasuga
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Seki
country: Japan
state: Gifu
city: Nayoro
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Tomakomai
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Morioka
country: Japan
state: Iwate
city: Yokohama
country: Japan
state: Kanagawa
city: Kahoku
country: Japan
state: Kanazawa
city: Kōchi
country: Japan
state: Kochi
city: Suzuka
country: Japan
state: Mie
city: Sendai
country: Japan
state: Miyagi
city: Nakagami
country: Japan
state: Okinawa
city: Kishiwada
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Sayama
country: Japan
state: Saitama
city: Shimotsuke
country: Japan
state: Tochigi
city: Adachi
country: Japan
state: Tokyo
city: Chiyoda
country: Japan
state: Tokyo
city: Hachiōji
country: Japan
state: Tokyo
city: Meguro
country: Japan
state: Tokyo
city: Minato-Ku
country: Japan
state: Tokyo
city: Minato
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Sakata
country: Japan
state: Yamagata
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
Study officials:
References:
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.