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Active, not recruiting Not applicable

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

NCT05326230 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2022-07-01
Last updated
2026-04-15

Condition(s) studied

HypertensionVascular DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Paradise™ (PRDS-001) Renal Denervation Ultrasound SystemRenal Angiogram

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

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

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

Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mean change in 24-hour systolic ABPM — From baseline to 3 months post-procedure

Trial sites (51)

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

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05326230 on ClinicalTrials.gov ↗ ← All trials in Japan