Clinical trial NCT05326230: A Clinical Study of the Paradise™ Renal Denervation System in Patients with Hypertension (RADIANCE-HTN DUO)
Official title: A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients with Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Denervation
Hypertension
Lead sponsor: Otsuka Medical Devices Co., Ltd. Japan
Sponsor class: INDUSTRY
First posted: 2022-04-13
Enrollment: 154
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Mean change in 24-hour systolic ABPM
timeFrame: From baseline to 3 months post-procedure
Secondary outcomes:
measure: Mean change in 24-hour systolic ABPM
timeFrame: from baseline to 6 months post-procedure
measure: Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
timeFrame: From baseline to 3, 6, 12 months post-procedure
measure: Change in mean sitting office blood pressure (systolic/diastolic)
timeFrame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
measure: Change in mean home blood pressure (systolic/diastolic)
timeFrame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
measure: Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
timeFrame: 3, 6, and 12months post-procedure
measure: Percentage of subjects who required a change in antihypertensive medication
timeFrame: at any time up to 12 months after the procedure
measure: Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
timeFrame: 3, 6, 12 months after the procedure
measure: Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
timeFrame: 3, 6, 12 months after the procedure
measure: Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
timeFrame: 3, 6, 12 months after the procedure
measure: Change in mean heart rate in the office, home, ABPM
timeFrame: 3, 6, 12 months after the procedure
Other outcomes:
Locations:
city: Hirosaki-shi
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Urayasu-shi
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Toon-shi
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka Sanno Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Iwaki-shi
country: Japan
facility: Iwaki City Medical Center
state: Fukushima
city: Seki-shi
country: Japan
facility: Chuno Kousei Hospital
state: Gifu
city: Hiroshima-shi
country: Japan
facility: Hiroshima City North Medical Center Asa Citizens Hospital
state: Hiroshima
city: Nayoro-shi
country: Japan
facility: Nayoro City General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo-Kosei General Hospital
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Tonan Hospital
state: Hokkaido
city: Tomakomai-shi
country: Japan
facility: Tomakomai City Hospital
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Nishinomiya-Shi
country: Japan
facility: Nishinomiya Municipal Central Hospital
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital
state: Kagoshima
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Nanbu Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Rosai Hospital
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Chikamori Hospital
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Suzuka-Shi
country: Japan
facility: Suzuka Chuo General Hospital
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Miyazaki Medical Association Hospital
state: Miyazaki
city: Niigata-shi
country: Japan
facility: Niigata City General Hospital
state: Niigata
city: Okayama-shi
country: Japan
facility: Okayama Rosai Hospital
state: Okayama
city: Naha-shi
country: Japan
facility: Ryukyu University Hospital
state: Okinawa
city: Osaka-shi
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital
state: Osaka
city: Sakai-shi
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Tosu-shi
country: Japan
facility: Imamura Hospital
state: Saga
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shimotsuke-shi
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Cyuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Minamino Junkanki Hospital
state: Tokyo
city: Meguro-Ku
country: Japan
facility: Kimura Clinic
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Medical Center Ohashi Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Saiseikai Central Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Takanawa Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Musashino-shi
country: Japan
facility: Japanese Red Cross Musashino Hospital
state: Tokyo
city: Ota-ku
country: Japan
facility: Tokyo Rosai Hospital
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Nissan Tamagawa Hospital
state: Tokyo
city: Yonago-shi
country: Japan
facility: Sanin Rosai Hospital
state: Tottori
city: Sakata-shi
country: Japan
facility: Nihonkai General Hospital
state: Yamagata
Study officials:
References: