Key result
Focused power ultrasound mediated perirenal fat modification is being evaluated in a randomized, sham-controlled trial to determine its efficacy in reducing blood pressure in patients with primary hypertension.
Why the study?
Perirenal fat plays a key role in sustaining pathological high blood pressure, but the efficacy of focused power ultrasound intervention targeting perirenal fat in primary hypertension is unknown.
Does perirenal fat modification using focused power ultrasound reduce office systolic blood pressure in patients with uncontrolled primary hypertension?
RCT (n=200)
Double-blind
1:1
Yes
Does perirenal fat modification using focused power ultrasound reduce office systolic blood pressure in patients with uncontrolled primary hypertension?
This trial protocol describes a novel, noninvasive approach using focused power ultrasound to modify perirenal fat as a potential treatment for uncontrolled primary hypertension.
First sham-controlled RCT of focused ultrasound perirenal fat modification in mild-moderate hypertension; will determine if this approach extends device-based options.
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.
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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 of office systolic blood pressure at 1-month compared with baseline. Focused power ultrasound mediated perirenal fat modification is being evaluated in a randomized, sham-controlled trial to determine its efficacy in reducing blood pressure in patients with primary hypertension.
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