The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.
Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
a decrease of average 24-hr ambulatory systolic BP from the baseline
Time frame: 3 month follow-up visit
a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively
Time frame: 3 month follow-up visit
a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively
Time frame: 3 month follow-up visit
a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline
Time frame: 3 month follow-up visit
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Unnamed facility
Hirosaki, Aomori, Japan
Unnamed facility
Urayasu, Chiba, Japan
Unnamed facility
Tōon, Ehime, Japan
Unnamed facility
Chikushino-shi, Fukuoka, Japan
Unnamed facility
Kasuga, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Sekimachi, Gifu, Japan
Unnamed facility
Nayoro, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 43 more locations