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

A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound System; Device: Renal Angiogram

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Aomori
    • Hirosaki-shi, Aomori, Japan
      • Hirosaki University Hospital
  • Chiba
    • Urayasu-shi, Chiba, Japan
      • Tokyo Bay Urayasu Ichikawa Medical Center
  • Ehime
    • Toon-shi, Ehime, Japan
      • Ehime University Hospital
  • Fukuoka
    • Chikushino-shi, Fukuoka, Japan
      • Fukuoka University Chikushi Hospital
    • Fukuoka, Fukuoka, Japan
      • Kyushu University Hospital
    • Fukuoka, Fukuoka, Japan
      • Fukuoka Sanno Hospital
    • Kurume-shi, Fukuoka, Japan
      • Kurume University Hospital
  • Fukushima
    • Iwaki, Fukushima, Japan
      • Iwaki City Medical Center
  • Gifu
    • Seki-shi, Gifu, Japan
      • Chuno Kousei Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan
      • Hiroshima City North Medical Center Asa Citizens Hospital
  • Hokkaido
    • Nayoro-shi, Hokkaido, Japan
      • Nayoro City General Hospital
    • Sapporo, Hokkaido, Japan
      • Sapporo-Kosei General Hospital
    • Sapporo, Hokkaido, Japan
      • Tonan Hospital
    • Tomakomai-shi, Hokkaido, Japan
      • Tomakomai City Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan
      • Kobe University Hospital
    • Nishinomiya-Shi, Hyōgo, Japan
      • Nishinomiya Municipal Central Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan
      • Kanazawa University Hospital
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan
      • Yokohama City University Hospital
    • Yokohama, Kanagawa, Japan
      • Yokohama Rosai Hospital
    • Yokohama, Kanagawa, Japan
      • Saiseikai Yokohamashi Nanbu Hospital
  • Kochi
    • Kochi, Kochi, Japan
      • Chikamori Hospital
  • Kumamoto
    • Kumamoto, Kumamoto, Japan
      • Kumamoto University Hospital
    • Kumamoto, Kumamoto, Japan
      • Japanese Red Cross Kumamoto Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan
      • University Hospital Kyoto Prefectural University of Medicine
  • Mie-ken
    • Suzuka-Shi, Mie-ken, Japan
      • Suzuka Chuo General Hospital
  • Miyagi
    • Sendai, Miyagi, Japan
      • Tohoku University Hospital
  • Miyazaki
    • Miyazaki, Miyazaki, Japan
      • Miyazaki Medical Association Hospital
  • Niigata
    • Niigata, Niigata, Japan
      • Niigata City General Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan
      • Okayama Rosai Hospital
  • Okinawa
    • Naha, Okinawa, Japan
      • Ryukyu University Hospital
  • Osaka
    • Osaka, Osaka, Japan
      • Osaka Saiseikai Nakatsu Hospital
    • Sakai-shi, Osaka, Japan
      • Osaka Rosai Hospital
    • Suita-shi, Osaka, Japan
      • Osaka University Hospital
    • Suita-shi, Osaka, Japan
      • National Cerebral and Cardiovascular Center
  • Saga-ken
    • Tosu-shi, Saga-ken, Japan
      • Imamura Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan
      • Hamamatsu University Hospital
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan
      • Jichi Medical University Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan
      • Mitsui Memorial Hospital
    • Cyuo-ku, Tokyo, Japan
      • St. Luke's International Hospital
    • Hachioji-shi, Tokyo, Japan
      • Minamino Junkanki Hospital
    • Meguro-Ku, Tokyo, Japan
      • Kimura Clinic
    • Meguro-ku, Tokyo, Japan
      • Toho University Medical Center Ohashi Hospital
    • Minato-ku, Tokyo, Japan
      • Tokyo Saiseikai Central Hospital
    • Minato-ku, Tokyo, Japan
      • Toranomon Hospital
    • Minato-ku, Tokyo, Japan
      • Tokyo Takanawa Hospital
    • Musashino-shi, Tokyo, Japan
      • Japanese Red Cross Musashino Hospital
    • Setagaya-ku, Tokyo, Japan
      • Nissan Tamagawa Hospital
    • Ōta-ku, Tokyo, Japan
      • Tokyo Rosai Hospital
  • Tottori
    • Yonago-shi, Tottori, Japan
      • Sanin Rosai Hospital
  • Yamagata
    • Sakata-shi, Yamagata, Japan
      • Nihonkai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Control; Renal Angiogram	Device: Renal Angiogram; Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Experimental: Renal Denervation; Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)	Device: 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; Other Names: Renal Angiogram/Renal Denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in 24-hour systolic ABPM	From baseline to 3 months post-procedure

Secondary Outcome Measures

Outcome Measure	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
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
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

Collaborators and Investigators

• Sponsor: Otsuka Medical Devices Co., Ltd. Japan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hypertension; Denervation
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: RDN-21-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No