Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Perirenal adipose tissue modification by focused power ultrasound

    Procedure/Surgery

    Perirenal adipose tissue modification by focused power ultrasound at both kidneys

  • Sham

    Procedure/Surgery

    Sham procedure of focused ultrasound at both kidneys

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Perirenal adipose tissue modification by focused power ultrasoundExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in 24h systolic blood pressure at the 6-month after treatment

Time frame
6 months after treatment

Secondary outcomes

1

Reduction in 24h ambulatory systolic/diastolic blood pressure

Time frame
1 month after treatment
2

Reductions in 24h ambulatory systolic/diastolic blood pressure

Time frame
3 months after treatment
3

Reduction in 24h ambulatory diastolic blood pressure

Time frame
6 months after treatment
4

Reduction in clinic systolic/diastolic blood pressure

Time frame
1 month after treatment

Other outcomes

1

The incidence rate of all-cause death

Time frame
6 months after treatment
2

The incidence of cardiovascular events

Time frame
6 months after treatment
3

The incidence of renal failure

Time frame
6 months after treatment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yan Li

Lead sponsor

Shanghai Institute of Hypertension

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: