CompletedNot Applicable

Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE-HTN-II)

China79 participantsStarted 2023-09-01

Plain-language summary

This randomized, blinded, sham-control trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and \<160 mmHg, and diastolic blood pressure\<100mmHg when not taking antihypertensive drugs for at least 1 month;
✓. Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP≥130 mmHg；
✓. The anteroposterior, transverse and axial diameters of inferior perirenal fat pad measured by ultrasound should be at least 20mm；
✓. Individual is willing to sign the informed consent of the study.

Exclusion criteria

✕. Individual with office systolic blood pressure (SBP) ≥ 160 mmHg and/or office diastolic blood pressure(DBP)≥ 100mmHg;
✕. Individual diagnosed as secondary hypertension (e.g. renal parenchymal hypertension, renal artery stenosis, primary aldosteronism, pheochromocytoma, Cushing's syndrome, aortic coarctation, obstructive sleep apnea hypopnea syndrome)；
✕. Individuals with ≥ 3 cardiovascular risk factors (male\>55 years old, female\>65 years old; smoking or passive smoking; 2-hour postprandial blood glucose 7.8-11mmol/L and/or impaired fasting glucose (6.1-6.9mmol/L); LDL-C ≥ 3.4mmol/L (130mg/dl), HDL-C\<1.0mmol/L (40mg/dl) or TC ≥ 5.2mmol/L (200mg/dl); Family history of early onset of cardiovascular disease, age of onset of first degree relatives\<50 years old; Abdominal obesity, waist circumference: male≥90cm, female≥85cm or BMI≥28kg/m2) or hypertensive target organ damage;
✕. Individuals taking other medications that may affect blood pressure (such as glucocorticoids);
✕. Individual with history of kidney or kidney surrounding tissue surgery;

What they're measuring

Ambulatory Blood Pressure

Timeframe: From baseline to 1 month post-procedure

Trial details

NCT IDNCT06018493

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-12

View on ClinicalTrials.gov More Hypertension trials