Resistant Hypertension Clinical Trial
Official title:
Renal Denervation by Allegro System in Patients With Resistant Hypertension
Verified date | December 2013 |
Source | Shanghai AngioCare Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 3 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Fuwai hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shanghai AngioCare Medical |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in office-based systolic blood pressure (SBP) from baseline to 6 months | 6 month | No | |
Secondary | 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 | No |
Secondary | • The incidence of major adverse events (MAE) at 1 month postrandomization | 1-month post randomization | Yes | |
Secondary | Office SBP and DBP at 1, 3, 6 months postrandomization | up to 6 months | No | |
Secondary | • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization | up to 6 months | No | |
Secondary | • MAE at 6-month post-randomization, including new renal artery stenosis >60% | up to 6 months | Yes |
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