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

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

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

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