Renal Denervation by Allegro System in Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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

Official Title
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Renal Denervation by Allegro System in Patients With Resistant Hypertension

Conditions
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Renal Denervation, Resistant Hypertension, Standard Medication

Intervention / Treatment
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* Device: renal denervation
* Other: standard medication


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery History of prior renal artery intervention including balloon angioplasty or stenting Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation) Renal artery abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard medication<br>Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic | Other: standard medication<br> <br> * Other names: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic;|
| Experimental: renal denervation<br>Allegro Renal Denervation System (AngioCare) | Device: renal denervation<br> <br> * Other names: Allegro Renal Denervation System (AngioCare);Other: standard medication<br> <br> * Other names: Standard Medication: Continued usage of 3 or more antihypertensive medications of different classes, including a diuretic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in office-based systolic blood pressure (SBP) from baseline to 6 months |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |