Sympathetic Mapping/ Ablation of Renal Nerves Trial

Summary

Participation Requirements

Description

This is a prospective, multicenter, single blind, randomized and controlled trial, in which patients are diagnosed with essential hypertension with at least six months of disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, conse...

This is a prospective, multicenter, single blind, randomized and controlled trial, in which patients are diagnosed with essential hypertension with at least six months of disease history and pharmacotherapy however their blood pressure still cannot be controlled. The patients will be informed, consent and get into a screening process. During the screening period patients will receive a standardized antihypertensive drug treatment for at least 28 days and office BP is still ? 150mmHg, ?180mmHg, and meet the inclusion and exclusion criteria. These patients will conduct renal artery angiography and be allocated to either renal sympathetic nerve denvervation group or renal artery angiography group by a randomizing system in a 1:1 ratio (212 patients, 106 paires). Patients with with office BP which is not achieved ideal level (<140 mmHg) will titrate doses of classes of antihypertensive drugs according to a predefined standardized medication regimen until their office BP <140 mmHg. Physicians who perform post-procedure patient management and physicians who perform renal denvervation procedures are blinded to each other. Patients will be followed at 7 days after the procedure or at discharge from hospital, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months and 12months. Urine samples will be collected for drug tests to determine drug compliance of a patient. Data collecting/management/statistical analysis and laboratory tests will be performed by independent, qualified organizations. Independent DSMB/CEC are formed and responsible for assessments of protocol deviations and natures of SAEs.

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