Hypertension, Vascular Diseases
Conditions
Keywords
denervation, resistant hypertension
Brief 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.
Detailed description
Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.
Interventions
PROCEDURESham Procedure
Sponsors
JIMRO Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a decrease of average 24-hr ambulatory systolic BP from the baseline | 3 month follow-up visit |
Secondary
| Measure | 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 |
Countries
Japan, South Korea
Outcome results
None listed