Background Perirenal 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. Methods A 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. Discussion The 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 registration ClinicalTrials.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.

Background Perirenal fat plays a key role in sustaining the pathological high blood pressure. We aim to investigate the efficacy of intervention for perirenal fat mediated by focused power ultrasound (FPU) on primary hypertension. Methods A 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 PFU or sham-procedure at a ratio of 1:1, and will be follow up on 24hours, 14days, 30days, and 90days after intervention. The primary endpoint is changes of office systolic blood pressure (SBP) at 30days compared with baseline. The secondary endpoints include the changes of office SBP from baseline to 90days, changes of 24-hours mean SBP from baseline to 30days and 90days, and changes of heart rate from baseline to 30days. Safety endpoint is defined as any severe adverse events related to the intervention. Discussion The 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 registration: ClinicalTrials.gov NCT05049096. Registered on September 7, 2021.