Status:
RECRUITING
A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
Lead Sponsor:
Otsuka Medical Devices Co., Ltd. Japan
Conditions:
Hypertension
Vascular Diseases
Eligibility:
All Genders
20-75 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT05326230
Start Date
July 1 2022
End Date
December 1 2032
Last Update
July 31 2025
Active Locations (51)
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1
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
2
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba, Japan
3
Ehime University Hospital
Toon-shi, Ehime, Japan
4
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan