Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension: a Multicenter, Randomized, Controlled Phase II/III Clinical Trial (PARADISE HTN-III)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Individual with office systolic blood pressure (SBP) ≥ 140 mmHg and \<160 mmHg, and office diastolic blood pressure (DBP)\<100mmHg after standardized antihypertensive drug treatment for 1 month;
• Individual with 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average systolic blood pressure (ASBP) ≥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.
Locations
Other Locations
China
The Affiliated Jiangning Hospital of Nanjing Medical University
RECRUITING
Nanjing
The first Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Suzhou Municipal Hospital
RECRUITING
Suzhou
Contact Information
Primary
Yanhui Sheng
yhsheng@njmu.edu.cn
13851647530
Backup
Yang Hua
759150674@qq.com
13851624359
Time Frame
Start Date:2024-03-01
Estimated Completion Date:2026-10
Participants
Target number of participants:30
Treatments
Experimental: Stage 1: Intervention group
This arm is combined with 3 groups and a total of 30 participants will be 1:1:1 allocated (each group with 10 participants).~Single treatment group: receive treatment once after enrollment; Consecutive treatment group A: receive 3 consecutive treatments, each with an interval of 3 days; Consecutive treatment group B: receive 3 consecutive treatments, each with an interval of 7 days. In Stage 1, the investigators will select optimal treatment strategy and proceed to Stage 2.
Active_comparator: Stage 2: Intervention group
Participants will receive optimal treatment strategy selected formerly in Stage 1
Sham_comparator: Stage 2: Sham-control group
In sham control group, participants will receive the sham control therapy (including peri-renal fat ultrasonic measurement and localization, focused ultrasound treatment parameters setting), however, without initiating the focused ultrasound equipment.
Collaborators: Affiliated Hospital of Nantong University, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Jiangning Hospital of Nanjing Medical University