Key result
Focused power ultrasound-mediated perirenal fat modification will be evaluated for its efficacy in reducing blood pressure in a planned randomized, sham-controlled trial of 200 patients with primary hypertension.
Why the study?
Perirenal fat sustains pathological high blood pressure, but whether perirenal fat modification mediated by focused power ultrasound can effectively treat primary hypertension remains to be investigated.
Does perirenal fat modification using focused power ultrasound reduce office systolic blood pressure in patients with uncontrolled primary hypertension?
RCT (n=200)
Double-blinded
1:1
Yes
Does perirenal fat modification using focused power ultrasound reduce office systolic blood pressure in patients with uncontrolled primary hypertension?
This protocol describes the first randomized, sham-controlled trial to evaluate noninvasive focused power ultrasound-mediated perirenal fat modification for blood pressure reduction in patients with essential hypertension.
First sham-controlled RCT of focused ultrasound perirenal fat modification in hypertension; will determine if this approach extends BP-lowering options.
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.
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Li et al. (2023) conducted an RCT in Primary hypertension (n=200). Focused power ultrasound-mediated perirenal fat modification vs. Sham procedure was evaluated on Changes in office systolic blood pressure at 1 month compared with baseline. Focused power ultrasound-mediated perirenal fat modification will be evaluated for its efficacy in reducing blood pressure in a planned randomized, sham-controlled trial of 200 patients with primary hypertension.
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