Perirenal Adipose Tissue Modification Therapy for Resistant Hypertension

ConditionResistant Hypertension

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorYan Li

About this trial

The goal of this clinical trial is to investigate if focused power ultrasound (FPU) targeted perirenal adipose tissue modification therapy would be effective and safe in treating resistant hypertension. The primary outcome of the study is the difference in the reduction of 24h mean systolic blood pressure between treatment and sham procedure groups 6 months after treatment. The secondary outcomes include the reduction of clinic blood pressure 1, 3, and 6 months after treatment, the reduction of 24h mean blood pressure 1, 3, and 6 months after treatment, and the drug burden of antihypertensive treatment. The safety evaluation includes the incidence of all-cause death, cardiovascular events (stroke and myocardial infarction), renal failure, and other adverse events.

Eligibility criteria

Qualifiers

Male or female participants aged 18-75 years old;

24h ambulatory systolic BP ≥130mmHg and <150mmHg, and 24h ambulatory diastolic BP <100mmHg after at least 4 weeks of combined treatment with 3 antihypertensive drugs (including a diuretic);

The ultrasound measured inferior perirenal adipose tissue ≥8 cm3 (with the superior-inferior diameter, left-right diameter, and anterior-posterior diameter all needing to be ≥20 mm);

Be willing to participate in the trial, and be able to visit doctors by himself or herself;

Disqualifiers

Secondary hypertension;

Occurrence of myocardial infarction, malignant arrhythmia, severe renal failure, or stroke within 6 months;

Ambulatory BP monitoring was invalid (<70% valid readings, or <20 daytime readings or <7 nighttime readings);

Alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin (TBL) above twice the normal range; eGFR (CKD-EPI) <45mL/min/1.73m2;

Trial design

Treatments tested in this trial

Perirenal adipose tissue modification by focused power ultrasound
Sham

Treatment groups

220 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Yan Li

Lead sponsor

Shanghai Institute of Hypertension

Sponsor institution

Source ClinicalTrials.gov