A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
NCT ID: NCT05326230
Last Updated: 2025-07-31
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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RECRUITING
NA
154 participants
INTERVENTIONAL
2022-07-01
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Renal Denervation
Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Sham Control
Renal Angiogram
Renal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Interventions
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Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Renal Angiogram
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.
* Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit
Exclusion Criteria
* Secondary hypertension other than sleep apnea
* Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
* Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
* Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
* Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
* Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
* Patients with a history of persistent or permanent atrial tachyarrhythmia
* Patients with active implantable medical devices
* Primary pulmonary hypertension
* Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
* Night shift workers
* Pregnant, nursing or planning to become pregnant
* Patients with any of the following central laboratory tests at screening
* Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
* HbA1c greater than or equal to 8.0%
* eGFR less than 40 mL/min/1.73m2
20 Years
75 Years
ALL
No
Sponsors
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Otsuka Medical Devices Co., Ltd. Japan
INDUSTRY
Responsible Party
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Locations
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Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba, Japan
Ehime University Hospital
Toon-shi, Ehime, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Iwaki City Medical Center
Iwaki, Fukushima, Japan
Chuno Kousei Hospital
Seki-shi, Gifu, Japan
Hiroshima City North Medical Center Asa Citizens Hospital
Hiroshima, Hiroshima, Japan
Nayoro City General Hospital
Nayoro-shi, Hokkaido, Japan
Sapporo-Kosei General Hospital
Sapporo, Hokkaido, Japan
Tonan Hospital
Sapporo, Hokkaido, Japan
Tomakomai City Hospital
Tomakomai-shi, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya-Shi, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Yokohama Rosai Hospital
Yokohama, Kanagawa, Japan
Chikamori Hospital
Kochi, Kochi, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Suzuka Chuo General Hospital
Suzuka-Shi, Mie-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, Japan
Niigata City General Hospital
Niigata, Niigata, Japan
Okayama Rosai Hospital
Okayama, Okayama-ken, Japan
Ryukyu University Hospital
Naha, Okinawa, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, Japan
Osaka Rosai Hospital
Sakai-shi, Osaka, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Imamura Hospital
Tosu-shi, Saga-ken, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo, Japan
St. Luke's International Hospital
Cyuo-ku, Tokyo, Japan
Minamino Junkanki Hospital
Hachioji-shi, Tokyo, Japan
Kimura Clinic
Meguro-Ku, Tokyo, Japan
Toho University Medical Center Ohashi Hospital
Meguro-ku, Tokyo, Japan
Tokyo Saiseikai Central Hospital
Minato-ku, Tokyo, Japan
Tokyo Takanawa Hospital
Minato-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan
Tokyo Rosai Hospital
Ōta-ku, Tokyo, Japan
Nissan Tamagawa Hospital
Setagaya-ku, Tokyo, Japan
Sanin Rosai Hospital
Yonago-shi, Tottori, Japan
Nihonkai General Hospital
Sakata-shi, Yamagata, Japan
Countries
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Central Contacts
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Facility Contacts
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Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Kentaro Ishinabe
Role: primary
Other Identifiers
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RDN-21-002
Identifier Type: -
Identifier Source: org_study_id
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