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

Hypertension Clinical Trial

— REQUIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918305
• Other study ID #: RDN-15-001
• Status: Completed
• Phase: Phase 3
• Start date: January 2017
• Est. completion date: October 2021

Study information

• Verified date: November 2021
• Source: JIMRO Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2021
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Vascular Diseases

Intervention

Device:
• PRDS-001 Renal Denervation Ultrasound System

Procedure:
• Sham Procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JIMRO Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a decrease of average 24-hr ambulatory systolic BP from the baseline		3 month follow-up visit
Secondary	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
Secondary	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
Secondary	a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline		3 month follow-up visit