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The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard medication | Placebo Comparator | Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic |
|
| renal denervation | Experimental | Allegro Renal Denervation System (AngioCare) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal denervation | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office-based systolic blood pressure (SBP) from baseline to 6 months | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months | Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months | 6 month |
| • The incidence of major adverse events (MAE) at 1 month postrandomization |
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Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Beijing | China |
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| standard medication |
| Other |
|
|
| 1-month post randomization |
| Office SBP and DBP at 1, 3, 6 months postrandomization | up to 6 months |
| • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization | up to 6 months |
| • MAE at 6-month post-randomization, including new renal artery stenosis >60% | up to 6 months |