Uncontrolled Hypertension
Conditions
Keywords
hypertension, uncontrolled hypertension, resistant hypertension
Brief summary
The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.
Interventions
DEVICEUltrasound-based Renal Denervation
Sponsors
Sound Interventions, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring) * Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic) * Renal artery diameter ≥5mm by digital angiography * Accessibility of renal vasculature
Exclusion criteria
* Estimated GFR \< 45 * Type 1 Diabetes * Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events | 30 days | All cause death, renal artery occlusion, renal artery stenosis, renal infarction and/or renal failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in office blood pressure measurement | 30 days, 3 months, 6 months, 9 months, 12 months | — |
| Change from baseline in ambulatory 24-hour blood pressure measurement | 6 months, 12 months | — |
| Change from baseline in renal artery dimensions | 30 days | Change in renal artery dimensions as measured by renal angiography, CT, or MRI |
| Change from baseline in creatinine | 6 months | — |
| Adverse events and device complications | 12 months | — |
Countries
Czechia
Contacts
Primary ContactDavid A. Smith
Outcome results
None listed