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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System) |
|
| Sham Control | Sham Comparator | Renal Angiogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paradise™ (PRDS-001) Renal Denervation Ultrasound System | Device | Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in 24-hour systolic ABPM | From baseline to 3 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in 24-hour systolic ABPM | from baseline to 6 months post-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 |
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Inclusion Criteria :
Exclusion Criteria
Lacks appropriate renal artery anatomy for renal denervation
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hirosaki University Hospital | Hirosaki-shi | Aomori | Japan | |||
| Tokyo Bay Urayasu Ichikawa Medical Center |
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|
| Renal Angiogram | Device | Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure |
|
| Change in mean sitting office blood pressure (systolic/diastolic) | From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure |
| Change in mean home blood pressure (systolic/diastolic) | From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure |
| 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 who required a change in antihypertensive medication | at any time up to 12 months after the procedure |
| Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication | 3, 6, 12 months after the procedure |
| Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication | 3, 6, 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 heart rate in the office, home, ABPM | 3, 6, 12 months after the procedure |
| 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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