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

Not Applicable

Recruiting

• Conditions: Vascular Diseases; Cardiovascular Diseases; Hypertension

• Registration Number: NCT05326230
• Lead Sponsor: Otsuka Medical Devices Co., Ltd. Japan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-13
• Study Start: 2022-07-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-31
• Primary Completion: 2026-12
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 whose blood pressure was controlled by changing antihypertensive medication	3, 6, 12 months after the procedure
Change in mean heart rate in the office, home, ABPM	3, 6, 12 months after the 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
Mean change in 24-hour systolic ABPM	from baseline to 6 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, 48, 60 months post-procedure
Percentage of subjects who required a change in antihypertensive medication	at any time up to 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 home blood pressure (systolic/diastolic)	From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication	3, 6, 12 months after the procedure

Trial Locations

Locations (51)

Hirosaki University Hospital; 🇯🇵 Hirosaki-shi, Aomori, Japan

Tokyo Bay Urayasu Ichikawa Medical Center; 🇯🇵 Urayasu-shi, Chiba, Japan

Ehime University Hospital; 🇯🇵 Toon-shi, Ehime, Japan

Fukuoka University Chikushi Hospital; 🇯🇵 Chikushino-shi, Fukuoka, Japan

Fukuoka Sanno Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kyushu University Hospital; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

Kurume University Hospital; 🇯🇵 Kurume-shi, Fukuoka, Japan

Iwaki City Medical Center; 🇯🇵 Iwaki-shi, Fukushima, Japan

Chuno Kousei Hospital; 🇯🇵 Seki-shi, Gifu, Japan

Hiroshima City North Medical Center Asa Citizens Hospital; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

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