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However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure \u2265150\/90\u2009mmHg and 24-hour ambulatory systolic blood pressure \u2265140\u2009mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (\u22126.6\u2009mmHg) and sham control (\u22126.5\u2009mmHg) groups (difference: \u22120.1, 95% confidence interval \u22125.5, 5.3;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.971). Reductions from baseline in home and office systolic blood pressure (differences: \u20131.8\u2009mmHg [\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.488] and \u22122.0\u2009mmHg [\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-\/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      NCT02918305 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1038\/s41440-021-00754-7","type":"journal-article","created":{"date-parts":[[2021,10,15]],"date-time":"2021-10-15T10:28:50Z","timestamp":1634293730000},"page":"221-231","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":134,"title":["Catheter-based 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YY has received consulting fees from JIMRO. KO has received honoraria and grant support from JIMURO. HU has received research grants from JIMRO. KS has received research grants from Daiichi-Sankyo and Nippon Boehringer Ingelheim. MN has received lecture fee from Terumo, Daiichi-Sankyo, Otsuka Medical Device and Tanabe Mitsubishi. KT has received consulting fees or speaking honorarium or both from Takeda, AstraZeneca, Novartis, Ono Pharmaceutical, Boehringer Ingelheim, Kyowa-kirin, Mochida, Daiichi-Sankyo, Astellas, Sanwa-Kagaku, Torii, Kowa, Eli Lilly, and has received operating funds from Otsuka Pharmaceutical, Takeda, Chugai, Kissei, Fuji, Kyowa-Kirin, Daiichi-Sankyo, Boehringer Ingelheim, Teijin, Dainippon-Sumitomo, Torii, Tanabe Mitsubishi, Merck Sharp & Dohme, and Bayer. HY has received honoraria from Otsuka Pharmaceutical, Terumo, Medicon, Daiichi-Sankyo, Nihon Medi-Physics and has received scholarship (educational) grant from Daiichi-Sankyo. HJK has received Patent royalties\/licensing fees from Daewoong Pharma. YS has received lecture fee from Otsuka Pharmaceutical. KS has received lecture fee from Otsuka Pharmaceutical. HT has received research funding from Otsuka Pharmaceutical. YM has unrestricted received research grant and lecture fee from Otsuka Pharmaceutical. SN has received consultation fees from JIMRO, Otsuka Medical Devices, Kyocera, Terumo and MDK medical and has received trust research\/joint research funds from Boston Scientific. All other authors declare no competing interests. PARADISE is a trademark of ReCor Medical, Inc. registered in the United States, the European Union, and Japan.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}