HypertensionNCT05326230

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

A study testing Paradise™ (PRDS-001) Renal Denervation Ultrasound System and Renal Angiogram in people with Hypertension and Vascular Diseases, run by Otsuka Medical Devices Co., Ltd. Japan at 51 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 75 years
Conditions the study is for: Hypertension, Vascular Diseases, Cardiovascular Diseases
What is being tested?: Paradise™ (PRDS-001) Renal Denervation Ultrasound System and Renal Angiogram
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 51 sitesJapan
Study dates: 1 Jul 2022to Dec 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

Japan51 sites

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

Other trials in Japan

About this study

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

Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases
Being tested: Paradise™ (PRDS-001) Renal Denervation Ultrasound System, Renal Angiogram
Keywords: Denervation, Hypertension
Medical subject headings: Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paradise™ (PRDS-001) Renal Denervation Ultrasound SystemDevice
Also called Renal Angiogram/Renal Denervation
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Renal AngiogramDevice
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Study groups in NCT05326230
Study group	Role	What they receive
Renal Denervation	Experimental	Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System) Receives: Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Sham Control	Sham comparator	Renal Angiogram Receives: Device: Renal Angiogram

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in 24-hour systolic ABPM
Measured: From baseline to 3 months post-procedure

Secondary outcomes (10)

Mean change in 24-hour systolic ABPM
Measured: from baseline to 6 months post-procedure
Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
Measured: From baseline to 3, 6, 12 months post-procedure
Change in mean sitting office blood pressure (systolic/diastolic)
Measured: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure
Change in mean home blood pressure (systolic/diastolic)
Measured: 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
Measured: 3, 6, and 12months post-procedure
Percentage of subjects who required a change in antihypertensive medication
Measured: at any time up to 12 months after the procedure
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Measured: 3, 6, 12 months after the procedure
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Measured: 3, 6, 12 months after the procedure
Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
Measured: 3, 6, 12 months after the procedure
Change in mean heart rate in the office, home, ABPM
Measured: 3, 6, 12 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 2022Dec 2032

First posted13 Apr 2022
Study start1 Jul 2022
Primary completionDec 2026 (estimated)
Study completionDec 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 154 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05326230
Sponsor's protocol ID: RDN-21-002
Status last verified: Jul 2025
First submitted: 6 Apr 2022
Last updated: 15 Apr 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension
ClinicalTrials.gov ID: NCT05326230
Acronym / sponsor ID: RDN-21-002
Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords: Denervation, Hypertension
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 154 participants (estimated)
Lead sponsor: Otsuka Medical Devices Co., Ltd. JapanIndustry (pharma, biotech, devices)
Study start: 1 Jul 2022 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2032 (estimated)
First posted: 13 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Renal Denervation	Experimental	Device: Paradise™ (PRDS-001) Renal Denervation Ultrasound SystemRenal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Sham Control	Sham comparator	Device: Renal AngiogramRenal Angiogram

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paradise™ (PRDS-001) Renal Denervation Ultrasound SystemAlso: Renal Angiogram/Renal DenervationFollowing renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control	Device	Renal Denervation
Renal AngiogramFollowing renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure	Device	Sham Control

Primary outcome

Mean change in 24-hour systolic ABPM
Time frame: From baseline to 3 months post-procedure

10 secondary outcomes

Mean change in 24-hour systolic ABPM
Time frame: from baseline to 6 months post-procedure
Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
Time frame: From baseline to 3, 6, 12 months post-procedure
Change in mean sitting office blood pressure (systolic/diastolic)
Time frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure
Change in mean home blood pressure (systolic/diastolic)
Time frame: 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
Time frame: 3, 6, and 12months post-procedure
Percentage of subjects who required a change in antihypertensive medication
Time frame: at any time up to 12 months after the procedure
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Time frame: 3, 6, 12 months after the procedure
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Time frame: 3, 6, 12 months after the procedure
Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
Time frame: 3, 6, 12 months after the procedure
Change in mean heart rate in the office, home, ABPM
Time frame: 3, 6, 12 months after the procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Individual participant dataSharing planned: No

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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in 24-hour systolic ABPM (time frame: From baseline to 3 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05326230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.