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

Overview

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.

Full Title of Study: “A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: July 2020

Detailed Description

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

Interventions

  • Device: PRDS-001 Renal Denervation Ultrasound System
  • Procedure: Sham Procedure

Arms, Groups and Cohorts

  • Sham Comparator: 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 Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • a decrease of average 24-hr ambulatory systolic BP from the baseline
    • Time Frame: 3 month follow-up visit

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • JIMRO Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor

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