The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.
Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(\>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)
Efficacy: Reduction of systolic blood pressure(SBP) and diastolic blood pressure(DBP) at six months as measured by office-based blood pressure assessment and ambulatory blood pressure monitoring(ABPM) compared to baseline
Time frame: 6 months after RDN
2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%)
Time frame: through 6 months
Reduction in 24-h ambulatory blood pressure(ABPM) parameters
Time frame: 1 month,3 months,6 months after RDN
Device or procedure related acute adverse events(Renal artery edema、mural thrombus,change in transcatheter blood pressure >20%,<20% compared to baseline、reduction of heart rate >20%)
Time frame: Perioperative period
Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission
Time frame: 1 month,3 months,6 months after RDN
Change in office SBP and DBP at 1, 3 months
Time frame: 1 month, 3 months after RDN
Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months
Time frame: 1 month, 3 months after RDN
Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50%
Time frame: 6 months after RDN
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