refractory essential hypertension
Conditions
Interventions
renal denervation
Sponsors
Osaka University Graduate School of Medicine, Cardiovascular medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged between 20 and 85 years old 2. a systolic blood pressure of >=160mmHg (>=150mmHg for Diabetes), despite compliance with three or more antihypertensive drugs 3. obtained written informed consent
Exclusion criteria
Exclusion criteria: 1. renal artery stenosis of more than 25%, renal stent implnataion, dual renal arteries 2. eGFR <30mL/min/1,73m2 3. average systolic BP <135mmmHg by ABPM 4. myocardial infarction or coronary intervention within 6 months 5. diabetes requiring insulin (type 1 diabetes) 6. secondary hypertension 7. bleeding tendency or impairment of coagulation system 8. terminal illness with life expectancy less than 12 months 9. participating in other clinical trial 10. pregnancy 11. ineligible for the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure elevation during renal pacing or renal denervation, Changes in blood pressure between before and after procedure at 1,3,6,and 12 months, Changes in ABPM between before and after procedure at 1,3,6,and 12 months, Relationship between post procedural blood pressure elevation during renal pacing and blood pressure lowering at follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| vital changes (blood pressure, heart rate) and pain during renal pacing, renal stenosis 3 months after procedure assessed by CT or MRI, Changes in laboratory data between before and after procedure at 1w, 1,3,6,and 12 months Adverse events | — |
Countries
Japan
Contacts
Public ContactYuji Okuyama
Osaka University Graduate School of Medicine Advanced Cardiovascular Therapeutics
Outcome results
None listed