Multicenter study of renal denervation system TCD-16164(feasibility study)
- Conditions
- Resistant hypertension and uncontrolled hypertension with difficulty of additional antihypertensive medication
- Registration Number
- JPRN-UMIN000027676
- Lead Sponsor
- TERUMO CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
Patients who are considered to be insufficient in terms of improvement in lifestyle and review of antihypertensive therapy. Patients who have poor adherence to medication. Patients who have received balloon angioplasty, stenting or renal denervation in the renal artery. Patients with a solitary kidney. Patients with eGFR of less than 40 mL/min/1.73 m2. Patients with a history of cardiac infarction, unstable angina or cerebrovascular disorder within 3 months before the procedure. Patients with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus. Patients having orthostatic hypotension Patients with secondary hypertension except for those derived from obstructive sleep apnea syndrome. Patients who lead a life where day and night are reversed. Patients with implanted ICD or CRT-D. Patients having conditions contraindicated to drugs using during intervention Patients who regularly use nonsteroidal anti-inflammatory drugs. Patient with renal artery stenosis with the rate of stenosis of 50% or over. Patients without the renal artery with a diameter between 3 mm and 8 mm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mean 24hr SBP at 3 months assessed by ABPM
- Secondary Outcome Measures
Name Time Method