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

JIMRO

Status and phase: Completed; Phase 3

Conditions: Hypertension; Vascular Diseases

Treatments: Procedure: Sham Procedure; Device: PRDS-001 Renal Denervation Ultrasound System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918305

RDN-15-001

Details and patient eligibility

About

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 description

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

Enrollment: 140 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

PRDS-001 Renal Denervation Ultrasound System

Sham Comparator group

Description:

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.

Treatment:

Device: PRDS-001 Renal Denervation Ultrasound System

Sham Procedure

Sham Comparator group

Description:

Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.

Treatment:

Procedure: Sham Procedure