1. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial
- Author
-
Tomoaki Matsumoto, Keisuke Okamura, Hidenori Urata, Chong Jin Kim, Kouichi Tamura, Satoko Nakamura, Keisuke Shinohara, Shuichi Seki, Woong Chol Kang, Naoto Inoue, Kazuhiko Yumoto, Keigo Dote, Satoaki Matoba, Ken-ichiro Sasaki, Hyun Jae Kang, Kazunori Horie, Takafumi Ueno, Akiko Matsuo, Taro Shibasaki, Yoshihiro Morino, Hisashi Kai, Tomokazu Ikemoto, Fumiki Yoshihara, Masato Nakamura, Seung-Hyuk Choi, Shigeo Sugawara, Kazuomi Kario, Yoshiaki Yokoi, Toshiyuki Takahashi, Hiroyoshi Yokoi, Eiichiro Yamamoto, Yukako Ogoyama, Yasushi Sakata, Yasushi Mukai, Chan Joon Kim, Yuhei Nojima, Shinsuke Nanto, Masahiko Fujihara, Yoshisato Shibata, Hiroshi Fujita, Hirofumi Tomita, and Jin Man Cho
- Subjects
Adult ,Catheters ,Ambulatory blood pressure ,Physiology ,Blood Pressure ,Kidney ,medicine.artery ,Internal Medicine ,Clinical endpoint ,Humans ,Medicine ,Sympathectomy ,Renal artery ,Adverse effect ,Antihypertensive Agents ,Denervation ,business.industry ,Comment ,Blood Pressure Monitoring, Ambulatory ,Catheter ,Treatment Outcome ,Blood pressure ,Anesthesia ,Hypertension ,Ambulatory ,Cardiology and Cardiovascular Medicine ,business - Abstract
Abstract Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. 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 ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) 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 (−6.6 mmHg) and sham control (−6.5 mmHg) groups (difference: −0.1, 95% confidence interval −5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: –1.8 mmHg [p = 0.488] and −2.0 mmHg [p = 0.511], 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. Clinical trial registration NCT02918305 (http://www.clinicaltrials.gov).
- Published
- 2021
- Full Text
- View/download PDF