Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELEPU Renal Denervation System
LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Lepu Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years * Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN) * 1\) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean 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
1. Clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 months after RDN |
| 2.Safety: The incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(>60%) | through 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic orthostatic hypotension, hypertensive emergency necessitating hospital admission | 1 month,3 months,6 months after RDN |
| Change in office SBP and DBP at 1, 3 months | 1 month, 3 months after RDN |
| Reduction in 24-h ambulatory blood pressure(ABPM) parameters | 1 month,3 months,6 months after RDN |
| Change in renal function at 6 months: Estimated glomerular filtration rate (eGFR) reduction >25%, 50% | 6 months after RDN |
| Change in average 24-hour SBP and DBP by ambulatory blood pressure monitoring (ABPM) at 1, 3 months | 1 month, 3 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%） | Perioperative period |
Outcome results
None listed