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NCT Number: NCT02918305

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hirosaki, Aomori, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRDS-001 Renal Denervation Ultrasound System

Device

Other names: renal denervation

Sham Procedure

Procedure

Other names: renal angiography

Primary outcomes

  1. a decrease of average 24-hr ambulatory systolic BP from the baseline

    Time frame: 3 month follow-up visit

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

JIMRO Co., Ltd.

Industry

Registry information

Official study title

A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension

Acronym: REQUIRE

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Sep 28, 2016
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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