Renal Denervation, Resistant Hypertension, Standard Medication
Conditions
Brief summary
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
Interventions
DEVICErenal denervation
OTHERstandard medication
Sponsors
Shanghai AngioCare Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 65 years at time of randomization * Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months * 1\) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg * Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation) * eGFR≥45 mL/min/1.73 m2 * Written informed consent
Exclusion criteria
* Type 1 diabetes mellitus * Secondary hypertension * Has an implantable cardioverter defibrillator (ICD) or pacemaker * Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period * Intravascular thrombosis or unstable atherosclerotic plaques * Has hemodynamically significant valvular heart disease * Pregnant, nursing, or planning to be pregnant * Any serious medical condition that may adversely affect the safety of the participant or the study * Currently enrolled in another investigational drug or device trial Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in office-based systolic blood pressure (SBP) from baseline to 6 months | 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months | 6 month | Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months |
| • The incidence of major adverse events (MAE) at 1 month postrandomization | 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 | — |
Countries
China
Outcome results
None listed