A Clinical Study of the Paradise™ Renal Denervation System in Patients with Hypertension (RADIANCE-HTN DUO)
- Conditions
- Vascular DiseasesCardiovascular DiseasesHypertension
- Interventions
- Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound SystemDevice: Renal Angiogram
- Registration Number
- NCT05326230
- Lead Sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Brief Summary
To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Denervation Paradise™ (PRDS-001) Renal Denervation Ultrasound System Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System) Sham Control Renal Angiogram Renal Angiogram
- Primary Outcome Measures
Name Time Method Mean change in 24-hour systolic ABPM From baseline to 3 months post-procedure
- Secondary Outcome Measures
Name Time Method Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg 3, 6, and 12months post-procedure Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication 3, 6, 12 months after the procedure Change in mean heart rate in the office, home, ABPM 3, 6, 12 months after the procedure Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints) From baseline to 3, 6, 12 months post-procedure Mean change in 24-hour systolic ABPM from baseline to 6 months post-procedure Change in mean sitting office blood pressure (systolic/diastolic) From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure Percentage of subjects who required a change in antihypertensive medication at any time up to 12 months after the procedure Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM 3, 6, 12 months after the procedure Change in mean home blood pressure (systolic/diastolic) From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication 3, 6, 12 months after the procedure
Trial Locations
- Locations (51)
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-shi, Fukuoka, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital
🇯🇵Kurume-shi, Fukuoka, Japan
Iwaki City Medical Center
🇯🇵Iwaki-shi, Fukushima, Japan
Chuno Kousei Hospital
🇯🇵Seki-shi, Gifu, Japan
Hiroshima City North Medical Center Asa Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Nayoro City General Hospital
🇯🇵Nayoro-shi, Hokkaido, Japan
Sapporo-Kosei General Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Tonan Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Tomakomai City Hospital
🇯🇵Tomakomai-shi, Hokkaido, Japan
Kobe University Hospital
🇯🇵Kobe-shi, Hyogo, Japan
Nishinomiya Municipal Central Hospital
🇯🇵Nishinomiya-Shi, Hyogo, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kagoshima University Hospital
🇯🇵Kagoshima-shi, Kagoshima, Japan
Saiseikai Yokohamashi Nanbu Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama Rosai Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Chikamori Hospital
🇯🇵Kochi-shi, Kochi, Japan
Japanese Red Cross Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Kumamoto University Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Suzuka Chuo General Hospital
🇯🇵Suzuka-Shi, Mie, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Miyazaki Medical Association Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Niigata City General Hospital
🇯🇵Niigata-shi, Niigata, Japan
Okayama Rosai Hospital
🇯🇵Okayama-shi, Okayama, Japan
Ryukyu University Hospital
🇯🇵Naha-shi, Okinawa, Japan
Osaka Saiseikai Nakatsu Hospital
🇯🇵Osaka-shi, 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, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu-shi, 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
🇯🇵Ota-ku, Tokyo, Japan
Nissan Tamagawa Hospital
🇯🇵Setagaya-ku, Tokyo, Japan
Sanin Rosai Hospital
🇯🇵Yonago-shi, Tottori, Japan
Nihonkai General Hospital
🇯🇵Sakata-shi, Yamagata, Japan