Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension

Phase 3

Completed

• Conditions: Hypertension; Vascular Diseases
• Interventions: Device: PRDS-001 Renal Denervation Ultrasound System; Procedure: Sham Procedure

• Registration Number: NCT02918305
• Lead Sponsor: JIMRO Co., Ltd.

Brief Summary

The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.

Detailed Description

Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Study Start: 2017-01
• Primary Completion: 2020-07
• Study Completion: 2021-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)
• 24-hr ambulatory BP 140 mmHg or greater.

Exclusion Criteria

• Secondary hypertension (sleep apnoea can be included.)
• Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater
• Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)
• eGFR<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)
• Known severe cardiovascular events within 3 months or severe cerebrovascular events
• Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months
• Concurrent persistent atrial fibrillation
• Patients those who are on active implantable medical devices
• Primary pulmonary hypertension
• Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRDS-001 Renal Denervation Ultrasound System	PRDS-001 Renal Denervation Ultrasound System	Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using PRDS-001 System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
Sham Procedure	Sham Procedure	Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.

Primary Outcome Measures

Name	Time	Method
a decrease of average 24-hr ambulatory systolic BP from the baseline	3 month follow-up visit

Secondary Outcome Measures

Name	Time	Method
a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline	3 month follow-up visit
a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively	3 month follow-up visit
a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively	3 month follow-up visit