Primary Hypertension
Conditions
Keywords
Primary Hypertension, Renal Denervation
Brief summary
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
Interventions
DEVICERenal denervation
After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.
DIAGNOSTIC_TESTRenal angiography
A renal angiography according to standard procedure.
Sponsors
Synaptic Medical Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Individual is ≥18 years and ≤65 years old. * Primary hypertension. * Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and\<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and \<170mmHg at the fourth week after screening.
Exclusion criteria
* Secondary hypertension. * History of prior renal artery intervention including balloon angioplasty or stenting. * Renal artery stenosis (≥50%) in either renal artery. * Main renal arteries with \<4mm, or \>8mm in diameter. * Main renal arteries with \<20mm in length. * Estimated glomerular filtration rate (eGFR) of \<40 ml/(min•1.73m2). * History of Stroke or TIA within 6 months prior to screening period. * History of Acute coronary syndrome within 6 months prior to screening period. * Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator. * Heart failure (NYHA classification Ⅲ-Ⅳ). * Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases. * History of cancer. * Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring. * Acute or severe systemic inflammatory response syndrome. * Any other serious medical condition unqualified to participate in this study evaluated by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring | from baseline to 3 months post-procedure | Primary effective outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in office systolic blood pressure | from baseline to 3 months post-procedure | Secondary effective outcome measure |
| Classes of anti-hypertensive medicine taken by participants | 6 months post-procedure | Secondary effective outcome measure |
| Incidence of achieving target office systolic blood pressure (office SBP<140mmHg) | from 3 months post-procedure to 6 months post-procedure | Secondary effective outcome measure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of renal stenosis | 6 months post-procedure | Safety outcome assessment |
| Other acute and chronic safety evaluating by the incidence of major adverse event | 6 months post-procedure | Safety outcome assessment |
| Change in serum creatinine | from baseline to 3 months post-procedure and 6 months post-procedure | Safety outcome assessment |
Countries
China
Contacts
Primary ContactJiayi Wang
Backup ContactQing Liu
Outcome results
None listed