Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study

Trials

Study Protocol

Yuqing Zhang¹  Menghuan Li²  Jing Shi²  Jiaming Yang²  Tingting Wu²  Wei Sun²  Xiangqing Kong³  Yanhui Sheng³  Kerui Zhang⁴ 

[1] Department of Cardiology, the Affiliated Jiangning Hospital of Nanjing Medical University, 210000, Nanjing, China;Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, 210000, Nanjing, China;Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, 210000, Nanjing, China;Gusu School, Nanjing Medical University, 215100, Suzhou, China;Gusu School, Nanjing Medical University, 215100, Suzhou, China;

关键词: Hypertension;    Blood pressure;    Perirenal fat;    Focused power ultrasound;    Therapy;    Randomized controlled trial;   

DOI  :  10.1186/s13063-023-07249-5

 received in 2023-02-13, accepted in 2023-03-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPerirenal fat plays a key role in sustaining pathological high blood pressure. We aim to investigate the efficacy of intervention for perirenal fat mediated by focused power ultrasound (FPU) on primary hypertension.MethodsA multicenter, randomized, sham-controlled, double-blinded trial will be implemented in 200 participants with mild to moderate hypertension. All enrolled participants will be randomly allocated to perirenal fat modification (PFM) intervention using FPU or sham-procedure at a ratio of 1:1 and will be followed up at 24 h, 14 days, 30 days, and 90 days after the intervention. The primary endpoint is changes in office systolic blood pressure (SBP) at 30 days compared with baseline. The secondary endpoints include the changes in office SBP from baseline to 90 days, changes in 24-h mean SBP from baseline to 30 days and 90 days, and changes in heart rate from baseline to 30 days. Safety endpoint is defined as any severe adverse events related to the intervention.DiscussionThe present study is the first to use noninvasive FPU to intervene in perirenal fat to achieve the goal of reducing blood pressure for patients with essential hypertension. Our study is expected to provide a new treatment strategy to control high blood pressure.Trial registrationClinicalTrials.gov. NCT05049096. Registered on September 7, 2021.Protocol version: Version 1.3.1, data 23 August 2021.Sponsor: Prof. Xiangqing Kong is the principal investigator of this trial.

【 授权许可】

CC BY   
© The Author(s) 2023