A clinical study of the ultrasonic renal denervation system (PRDS-001) in patients with hypertension (RADIANCE-HTN DUO)

Otsuka Medical Devices Co., Ltd.0 个研究点目标入组 154 人开始时间: 2022年7月13日最近更新: 2024年10月7日

适应症

试验速览

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•Patients who have received antihypertensive treatment with two antihypertensive drugs 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

•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 or plasma aldosterone greater than or equal to 60 pg/ml
•HbA1c greater than or equal to 8.0%
•eGFR less than 40 mL/min/1.73m^2

Primary endpoint: Mean change in 24-hour systolic ABPM from baseline to 3 months post-procedure

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

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