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

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

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

Conditions
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Hypertension, Vascular Diseases

Intervention / Treatment
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* Device: PRDS-001 Renal Denervation Ultrasound System
* Procedure: Sham Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: PRDS-001 Renal Denervation Ultrasound System<br>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. | Device: PRDS-001 Renal Denervation Ultrasound System<br> <br> * Other names: renal denervation;|
| Sham Comparator: Sham Procedure<br>Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure. | Procedure: Sham Procedure<br> <br> * Other names: renal angiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a decrease of average 24-hr ambulatory systolic BP from the baseline |  | 3 month follow-up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline |  | 3 month follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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denervation, resistant hypertension