Phase
Condition
Vascular Diseases
Circulation Disorders
Stress
Treatment
Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Renal Angiogram
Clinical Study ID
Ages 20-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria :
Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.
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
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
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
Study Design
Connect with a study center
Hirosaki University Hospital
Hirosaki-shi, Aomori
JapanActive - Recruiting
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba
JapanActive - Recruiting
Ehime University Hospital
Toon-shi, Ehime
JapanActive - Recruiting
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka
JapanActive - Recruiting
Fukuoka Sanno Hospital
Fukuoka-shi, Fukuoka
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka-shi, Fukuoka
JapanActive - Recruiting
Kurume University Hospital
Kurume-shi, Fukuoka
JapanActive - Recruiting
Iwaki City Medical Center
Iwaki-shi, Fukushima
JapanActive - Recruiting
Chuno Kousei Hospital
Seki-shi, Gifu
JapanActive - Recruiting
Hiroshima City North Medical Center Asa Citizens Hospital
Hiroshima-shi, Hiroshima
JapanActive - Recruiting
Nayoro City General Hospital
Nayoro-shi, Hokkaido
JapanActive - Recruiting
Sapporo-Kosei General Hospital
Sapporo-shi, Hokkaido
JapanActive - Recruiting
Tonan Hospital
Sapporo-shi, Hokkaido
JapanActive - Recruiting
Tomakomai City Hospital
Tomakomai-shi, Hokkaido
JapanActive - Recruiting
Kobe University Hospital
Kobe-shi, Hyogo
JapanActive - Recruiting
Nishinomiya Municipal Central Hospital
Nishinomiya-Shi, Hyogo
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa-shi, Ishikawa
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima-shi, Kagoshima
JapanActive - Recruiting
Saiseikai Yokohamashi Nanbu Hospital
Yokohama-shi, Kanagawa
JapanSite Not Available
Yokohama City University Hospital
Yokohama-shi, Kanagawa
JapanActive - Recruiting
Yokohama Rosai Hospital
Yokohama-shi, Kanagawa
JapanActive - Recruiting
Chikamori Hospital
Kochi-shi, Kochi
JapanActive - Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto-shi, Kumamoto
JapanActive - Recruiting
Kumamoto University Hospital
Kumamoto-shi, Kumamoto
JapanActive - Recruiting
University Hospital Kyoto Prefectural University of Medicine
Kyoto-shi, Kyoto
JapanActive - Recruiting
Suzuka Chuo General Hospital
Suzuka-Shi, Mie
JapanActive - Recruiting
Tohoku University Hospital
Sendai-shi, Miyagi
JapanActive - Recruiting
Miyazaki Medical Association Hospital
Miyazaki-shi, Miyazaki
JapanActive - Recruiting
Niigata City General Hospital
Niigata-shi, Niigata
JapanActive - Recruiting
Okayama Rosai Hospital
Okayama-shi, Okayama
JapanActive - Recruiting
Ryukyu University Hospital
Naha-shi, Okinawa
JapanActive - Recruiting
Osaka Saiseikai Nakatsu Hospital
Osaka-shi, Osaka
JapanSite Not Available
Osaka Rosai Hospital
Sakai-shi, Osaka
JapanActive - Recruiting
National Cerebral and Cardiovascular Center
Suita-shi, Osaka
JapanActive - Recruiting
Osaka University Hospital
Suita-shi, Osaka
JapanActive - Recruiting
Imamura Hospital
Tosu-shi, Saga
JapanActive - Recruiting
Hamamatsu University Hospital
Hamamatsu-shi, Shizuoka
JapanActive - Recruiting
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi
JapanActive - Recruiting
Jichi Medical University Hospital
Shimotuke-shi, Tochigi
JapanSite Not Available
Mitsui Memorial Hospital
Chiyoda-ku, Tokyo
JapanActive - Recruiting
St. Luke's International Hospital
Cyuo-ku, Tokyo
JapanSite Not Available
Minamino Junkanki Hospital
Hachioji-shi, Tokyo
JapanActive - Recruiting
Minamino Junkanki Hospital
Hachioji-shi, Tokyo, Tokyo
JapanSite Not Available
Kimura Clinic
Meguro-Ku, Tokyo
JapanActive - Recruiting
Toho University Medical Center Ohashi Hospital
Meguro-ku, Tokyo
JapanActive - Recruiting
Tokyo Saiseikai Central Hospital
Minato-ku, Tokyo
JapanActive - Recruiting
Tokyo Takanawa Hospital
Minato-ku, Tokyo
JapanActive - Recruiting
Toranomon Hospital
Minato-ku, Tokyo
JapanActive - Recruiting
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo
JapanActive - Recruiting
Tokyo Rosai Hospital
Ota-ku, Tokyo
JapanActive - Recruiting
Nissan Tamagawa Hospital
Setagaya-ku, Tokyo
JapanActive - Recruiting
Sanin Rosai Hospital
Yonago-shi, Tottori
JapanSite Not Available
Nihonkai General Hospital
Sakata-shi, Yamagata
JapanActive - Recruiting
Fukuoka University Chikushi Hospital
Fukuoka,
JapanSite Not Available
Japanese Red Cross Kumamoto Hospital
Kumamoto,
JapanSite Not Available
Miyazaki Medical Association Hospital
Miyazaki,
JapanSite Not Available
Jichi Medical University Hospital
Tochigi,
JapanSite Not Available
Mitsui Memorial Hospital
Tokyo,
JapanSite Not Available
Nihonkai General Hospital
Yamagata,
JapanSite Not Available
Yokohama Rosai Hospital
Yokohama,
JapanSite Not Available
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