Although randomized trials have demonstrated there is no benefit of renal-artery stenting in addition to medical therapy for patients with atherosclerosis renal artery stenosis, many patients indeed gained benefit in daily practices after stenting, such as reduction in blood pressure and recovery in renal functions. One important gap is that there is no universal standard to determine whether to stent in these patients. Fraction Flow Reserve (FFR) has been studied for many year in chronic coronary heart disease and FFR-guided revascularization strategy is known to be better than both angiography-guided revascularization and medication alone. The goal of this clinical trial is to learn whether Fraction Flow Reserve (FFR) is appropriate to determine stenting in hypertension patients with atherosclerosis renal artery stenosis. The main questions it aims to answer are: * Is it appropriate to use FFR to determine whether or not stenting for hypertension patients with atherosclerosis renal artery stenosis? * To provide detailed data supporting design of further trial, such as sample size calculating, cut-off value for FFR in renal artery stenosis, etc. Participants met the inclusive/exclusive criteria will be randomized to stenting or not in the renal artery, then hyperemic FFR induced by dopamine will be measured in all participants. If FFR is ≥0.80, randomization will be applied. If FFR is \<0.80, randomization will be ignored, and stenting will be performed as planned. The blood pressure and anti-hypertensive medications will be compared before and 3 months after the procedure based on ambulatory blood pressure monitoring, all participants will be followed up for 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
100
A bolus dose of 50μg/kg dopamine via renal artery to induce hyperemic status
Renal FFR will be measured based on SOP
Renal artery stenting will be implanted based on the protocol
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Chao-yang hospital, capital medical university
Beijing, Beijing Municipality, China
RECRUITINGBeijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGQinghai province cardiovascular and cerebrovascular disease specialist hospital
Xining, Qinghai, China
RECRUITINGZibo Central Hospital
Zibo, Shandong, China
RECRUITING...and 3 more locations
Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From baseline to 3 months post-procedure
Change in the composite index of antihypertensive drugs
Change in the composite index of antihypertensive drugs. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)
Time frame: From baseline to 3 months post-procedure
Change in systolic blood pressure as measured by 24-hour ABPM
Time frame: From baseline to 3 months post-procedure
Change in diastolic blood pressure as measured by 24-hour ABPM
Time frame: From baseline to 3 months post-procedure
Change in home blood pressure
Time frame: From baseline to 3 months post-procedure
Change in office blood pressure
Time frame: From baseline to 3 months post-procedure
Change in the composite index of antihypertensive drugs to reach target blood pressure
Change in the composite index of antihypertensive drugs to reach target blood pressure. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)
Time frame: From baseline to 1 year post-procedure
Change in ABPM
Time frame: From baseline to 6 months, 1 year post-procedure
All-cause death
Time frame: From baseline to 1 year post-procedure
Cardiac death
Time frame: From baseline to 1 year post-procedure
Acute myocardial infarction incidence
Based on universal definition of acute myocardial infarction
Time frame: From baseline to 1 year post-procedure
Non-fatal stroke incidence
Based on medical records under outcome committee's judge
Time frame: From baseline to 1 year post-procedure
Rehospitalization due to heart failure incidence
Based on medical records under outcome committee's judge
Time frame: From baseline to 1 year post-procedure
Increase in serum creatinine or dialysis
Time frame: From baseline to 1 year post-procedure
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