Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT07232966
Eligibility Criteria:
Inclusion Criteria:
1. Male or female participants aged 18-75 years old;
2. 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);
3. 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);
4. Be willing to participate in the trial, and be able to visit doctors by himself or herself;
5. Sign the informed consent form.
Exclusion Criteria:
1. Secondary hypertension;
2. Occurrence of myocardial infarction, malignant arrhythmia, severe renal failure, or stroke within 6 months;
3. Ambulatory BP monitoring was invalid (\<70% valid readings, or \<20 daytime readings or \<7 nighttime readings);
4. Alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin (TBL) above twice the normal range; eGFR (CKD-EPI) \<45mL/min/1.73m2;
5. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (glycated hemoglobin ≥8.5%);
6. Single functionally normal kidney or presence of renal malignant tumor;
7. Bilateral skin diseases at renal region that are not suitable for the therapy;
8. Women in pregnancy, lactating, or planning for pregnancy;
9. Other concomitant diseases that are considered not suitable for participation in the trial;
10. Patients have contraindications to angiotensin receptor-neprilysin inhibitor (ARNIs), thiazide-like diuretic drugs, or calcium channel blocker (CCBs);
11. Non-compliant patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07232966
Study Brief:
Protocol Section:
NCT07232966