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

NCT05326230 | Active Not Recruiting

• 1 other identifier: RDN-21-002
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 51

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.

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Keywords

Denervation; Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean change in 24-hour systolic ABPM

  From baseline to 3 months post-procedure

Secondary Outcomes (10)

• 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

• 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

Study Arms (2)

Renal Denervation

EXPERIMENTAL

Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)

Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Sham Control

SHAM COMPARATOR

Renal Angiogram

Device: Renal Angiogram

Interventions

Renal Angiogram DEVICE

Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Sham Control

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

Also known as: Renal Angiogram/Renal Denervation

Renal Denervation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (51)

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

Location

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu-shi, Chiba, Japan

Location

Ehime University Hospital

Toon-shi, Ehime, Japan

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Location

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Location

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Location

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Location

Iwaki City Medical Center

Iwaki, Fukushima, Japan

Location

Chuno Kousei Hospital

Seki-shi, Gifu, Japan

Location

Hiroshima City North Medical Center Asa Citizens Hospital

Hiroshima, Hiroshima, Japan

Location

Nayoro City General Hospital

Nayoro-shi, Hokkaido, Japan

Location

Sapporo-Kosei General Hospital

Sapporo, Hokkaido, Japan

Location

Tonan Hospital

Sapporo, Hokkaido, Japan

Location

Tomakomai City Hospital

Tomakomai-shi, Hokkaido, Japan

Location

Kobe University Hospital

Kobe, Hyōgo, Japan

Location

Nishinomiya Municipal Central Hospital

Nishinomiya-Shi, Hyōgo, Japan

Location

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Location

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital

Yokohama, Kanagawa, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

Location

Yokohama Rosai Hospital

Yokohama, Kanagawa, Japan

Location

Chikamori Hospital

Kochi, Kochi, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Location

Suzuka Chuo General Hospital

Suzuka-Shi, Mie-ken, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Location

Niigata City General Hospital

Niigata, Niigata, Japan

Location

Okayama Rosai Hospital

Okayama, Okayama-ken, Japan

Location

Ryukyu University Hospital

Naha, Okinawa, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, Japan

Location

Osaka Rosai Hospital

Sakai-shi, Osaka, Japan

Location

National Cerebral and Cardiovascular Center

Suita-shi, Osaka, Japan

Location

Osaka University Hospital

Suita-shi, Osaka, Japan

Location

Imamura Hospital

Tosu-shi, Saga-ken, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, Japan

Location

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Location

Mitsui Memorial Hospital

Chiyoda-ku, Tokyo, Japan

Location

St. Luke's International Hospital

Cyuo-ku, Tokyo, Japan

Location

Minamino Junkanki Hospital

Hachioji-shi, Tokyo, Japan

Location

Kimura Clinic

Meguro-Ku, Tokyo, Japan

Location

Toho University Medical Center Ohashi Hospital

Meguro-ku, Tokyo, Japan

Location

Tokyo Saiseikai Central Hospital

Minato-ku, Tokyo, Japan

Location

Tokyo Takanawa Hospital

Minato-ku, Tokyo, Japan

Location

Toranomon Hospital

Minato-ku, Tokyo, Japan

Location

Japanese Red Cross Musashino Hospital

Musashino-shi, Tokyo, Japan

Location

Tokyo Rosai Hospital

Ōta-ku, Tokyo, Japan

Location

Nissan Tamagawa Hospital

Setagaya-ku, Tokyo, Japan

Location

Sanin Rosai Hospital

Yonago-shi, Tottori, Japan

Location

Nihonkai General Hospital

Sakata-shi, Yamagata, Japan

Location

MeSH Terms

Conditions

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 13, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 15, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (51)