A Clinical Study of the Paradise™ Renal Denervation System in Patients with Hypertension (RADIANCE-HTN DUO)

Last updated: October 3, 2024
Sponsor: Otsuka Medical Devices Co., Ltd. Japan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Stress

Treatment

Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Renal Angiogram

Clinical Study ID

NCT05326230
RDN-21-002
  • Ages 20-75
  • All Genders

Study 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.

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

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori
    Japan

    Active - Recruiting

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu-shi, Chiba
    Japan

    Active - Recruiting

  • Ehime University Hospital

    Toon-shi, Ehime
    Japan

    Active - Recruiting

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, Fukuoka
    Japan

    Active - Recruiting

  • Fukuoka Sanno Hospital

    Fukuoka-shi, Fukuoka
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka
    Japan

    Active - Recruiting

  • Iwaki City Medical Center

    Iwaki-shi, Fukushima
    Japan

    Active - Recruiting

  • Chuno Kousei Hospital

    Seki-shi, Gifu
    Japan

    Active - Recruiting

  • Hiroshima City North Medical Center Asa Citizens Hospital

    Hiroshima-shi, Hiroshima
    Japan

    Active - Recruiting

  • Nayoro City General Hospital

    Nayoro-shi, Hokkaido
    Japan

    Active - Recruiting

  • Sapporo-Kosei General Hospital

    Sapporo-shi, Hokkaido
    Japan

    Active - Recruiting

  • Tonan Hospital

    Sapporo-shi, Hokkaido
    Japan

    Active - Recruiting

  • Tomakomai City Hospital

    Tomakomai-shi, Hokkaido
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe-shi, Hyogo
    Japan

    Active - Recruiting

  • Nishinomiya Municipal Central Hospital

    Nishinomiya-Shi, Hyogo
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa-shi, Ishikawa
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima-shi, Kagoshima
    Japan

    Active - Recruiting

  • Saiseikai Yokohamashi Nanbu Hospital

    Yokohama-shi, Kanagawa
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama-shi, Kanagawa
    Japan

    Active - Recruiting

  • Yokohama Rosai Hospital

    Yokohama-shi, Kanagawa
    Japan

    Active - Recruiting

  • Chikamori Hospital

    Kochi-shi, Kochi
    Japan

    Active - Recruiting

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto-shi, Kumamoto
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto-shi, Kumamoto
    Japan

    Active - Recruiting

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto-shi, Kyoto
    Japan

    Active - Recruiting

  • Suzuka Chuo General Hospital

    Suzuka-Shi, Mie
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi
    Japan

    Active - Recruiting

  • Miyazaki Medical Association Hospital

    Miyazaki-shi, Miyazaki
    Japan

    Active - Recruiting

  • Niigata City General Hospital

    Niigata-shi, Niigata
    Japan

    Active - Recruiting

  • Okayama Rosai Hospital

    Okayama-shi, Okayama
    Japan

    Active - Recruiting

  • Ryukyu University Hospital

    Naha-shi, Okinawa
    Japan

    Active - Recruiting

  • Osaka Saiseikai Nakatsu Hospital

    Osaka-shi, Osaka
    Japan

    Site Not Available

  • Osaka Rosai Hospital

    Sakai-shi, Osaka
    Japan

    Active - Recruiting

  • National Cerebral and Cardiovascular Center

    Suita-shi, Osaka
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-shi, Osaka
    Japan

    Active - Recruiting

  • Imamura Hospital

    Tosu-shi, Saga
    Japan

    Active - Recruiting

  • Hamamatsu University Hospital

    Hamamatsu-shi, Shizuoka
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi
    Japan

    Active - Recruiting

  • Jichi Medical University Hospital

    Shimotuke-shi, Tochigi
    Japan

    Site Not Available

  • Mitsui Memorial Hospital

    Chiyoda-ku, Tokyo
    Japan

    Active - Recruiting

  • St. Luke's International Hospital

    Cyuo-ku, Tokyo
    Japan

    Site Not Available

  • Minamino Junkanki Hospital

    Hachioji-shi, Tokyo
    Japan

    Active - Recruiting

  • Minamino Junkanki Hospital

    Hachioji-shi, Tokyo, Tokyo
    Japan

    Site Not Available

  • Kimura Clinic

    Meguro-Ku, Tokyo
    Japan

    Active - Recruiting

  • Toho University Medical Center Ohashi Hospital

    Meguro-ku, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Saiseikai Central Hospital

    Minato-ku, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Takanawa Hospital

    Minato-ku, Tokyo
    Japan

    Active - Recruiting

  • Toranomon Hospital

    Minato-ku, Tokyo
    Japan

    Active - Recruiting

  • Japanese Red Cross Musashino Hospital

    Musashino-shi, Tokyo
    Japan

    Active - Recruiting

  • Tokyo Rosai Hospital

    Ota-ku, Tokyo
    Japan

    Active - Recruiting

  • Nissan Tamagawa Hospital

    Setagaya-ku, Tokyo
    Japan

    Active - Recruiting

  • Sanin Rosai Hospital

    Yonago-shi, Tottori
    Japan

    Site Not Available

  • Nihonkai General Hospital

    Sakata-shi, Yamagata
    Japan

    Active - Recruiting

  • Fukuoka University Chikushi Hospital

    Fukuoka,
    Japan

    Site Not Available

  • Japanese Red Cross Kumamoto Hospital

    Kumamoto,
    Japan

    Site Not Available

  • Miyazaki Medical Association Hospital

    Miyazaki,
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Tochigi,
    Japan

    Site Not Available

  • Mitsui Memorial Hospital

    Tokyo,
    Japan

    Site Not Available

  • Nihonkai General Hospital

    Yamagata,
    Japan

    Site Not Available

  • Yokohama Rosai Hospital

    Yokohama,
    Japan

    Site Not Available

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