Hypertensie Chronic kidney disease (or) chronic renal disease high blood pressure Hypertension
Conditions
Sponsors
Ardian, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Individual has a systolic blood pressure higher than 160 mmHg (higher than 150 mmHg for type 2 diabetics).;2. Individual is adhering to a stable drug regimen including 3 or more antihypertensive medications (with no changes for a minimum of 2 weeks prior to enrollment) that is expected to be maintained for at least 6 months.;3. Individual is *18 and * 85 years of age.
Exclusion criteria
Exclusion criteria: 1. Individual has anatomically abnormal renal artery (this is defined in detail in the study protocol on page 13).;2. Individual has an estimated glomerular filtration rate (eGFR) of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of kidney denervation on blood pressure from baseline to 6 months post-denervation. Expected outcome: - Substantial decrease in blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety (this is extensively described in the study protocol page 16) o Acute Procedural Safety * to be compared against other common interventions (renal stenting, angioplasty, etc.) o 6 Month Safety *compared between groups at 6 months postrandomization eGFR drop of >25% o Composite Cardiovascular Endpoint * compared between groups at 6 months post-randomization -Blood pressure reduction: o Incidence of achieving target SBP (SBP 10 mmHg reduction in SBP at 6 months post-randomization. o Incidence of high blood pressure actions and low blood pressure actions through 6 months post-randomization. o Change in Office Diastolic Blood Pressure (DBP) from baseline to 6 months post-randomization o Change in 24 hour ambulatory blood pressure from baseline to 6 months post-randomization. o Changes in SBP and DBP from baseline to 12, 18, 24, 30 & 36 months after renal denervation. - Left Ventricular (LV) Function: among patients with LV hypertrophy at baseline, change in LV mass at 6 months following renal denervation. | — |
Countries
Netherlands
Outcome results
None listed