Clinical trial NCT03511313: Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
Official title: A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Hypertension
Keywords: Primary Hypertension
Renal Denervation
Lead sponsor: Synaptic Medical Corporation
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
timeFrame: from baseline to 3 months post-procedure
Secondary outcomes:
measure: Change in office systolic blood pressure
timeFrame: from baseline to 3 months post-procedure
measure: Classes of anti-hypertensive medicine taken by participants
timeFrame: 6 months post-procedure
measure: Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)
timeFrame: from 3 months post-procedure to 6 months post-procedure
Other outcomes:
measure: Change in serum creatinine
timeFrame: from baseline to 3 months post-procedure and 6 months post-procedure
measure: Incidence of renal stenosis
timeFrame: 6 months post-procedure
measure: Other acute and chronic safety evaluating by the incidence of major adverse event
timeFrame: 6 months post-procedure
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo
role: PRINCIPAL_INVESTIGATOR
References: