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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Mean change in 24-hour systolic ABPM
Time frame: From baseline to 3 months post-procedure
Mean change in 24-hour systolic ABPM
Time frame: from baseline to 6 months post-procedure
Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
Time frame: From baseline to 3, 6, 12 months post-procedure
Change in mean sitting office blood pressure (systolic/diastolic)
Time frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Change in mean home blood pressure (systolic/diastolic)
Time frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 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
Time frame: 3, 6, and 12months post-procedure
Percentage of subjects who required a change in antihypertensive medication
Time frame: at any time up to 12 months after the procedure
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Time frame: 3, 6, 12 months after the procedure
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Time frame: 3, 6, 12 months after the procedure
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Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
TERMINATEDTokyo Bay Urayasu Ichikawa Medical Center
Urayasu-shi, Chiba, Japan
RECRUITINGEhime University Hospital
Toon-shi, Ehime, Japan
TERMINATEDFukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
TERMINATEDFukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGKyushu University Hospital
Fukuoka, Fukuoka, Japan
RECRUITINGKurume University Hospital
Kurume-shi, Fukuoka, Japan
RECRUITINGIwaki City Medical Center
Iwaki, Fukushima, Japan
TERMINATEDChuno Kousei Hospital
Seki-shi, Gifu, Japan
TERMINATEDHiroshima City North Medical Center Asa Citizens Hospital
Hiroshima, Hiroshima, Japan
TERMINATED...and 41 more locations
Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
Time frame: 3, 6, 12 months after the procedure
Change in mean heart rate in the office, home, ABPM
Time frame: 3, 6, 12 months after the procedure