Fractional Flow Reserve to Determine the ApproprIateness of Percutaneous Renal Artery Intervention in Atherosclerosis Renovascular Hypertension Patients: a Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With recorded hypertension, AND the blood pressure is not controlled (SBP ≥140mmHg and/or DBP ≥90mmHg) on 2 or more classes of anti-hypertensive drugs;
- •Evidence of renal artery stenosis and undergoing renal artery angiography;
- •Able to follow the study protocol and provide informed consent;
- •Renal artery angiography shows at least 1 main artery with stenosis of 50%-90%, AND the diameter is ≥ 4.0mm.
排除标准
- •SBP ≥200mmHg and/or DBP ≥120mmHg at the day or randomization;
- •Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis;
- •Pregnancy or unknow pregnancy status in female of childbearing potential;
- •Participation in any drug or device trial during the study period;
- •Any stroke/TIA, OR with ≥70% stenosis of carotid artery;
- •Any major surgery, myocardial infarction or interventional therapy 30 days prior to study entry;
- •LVEF <30%;
- •Comorbid condition causing life expectancy ≤1 year;
- •Allergy to contrast or any of the following: aspirin, clopidogrel;
- •Previous kidney transplant;
- •Previous renal artery bypass surgery or stent intervention;
- •Kidney size less than 8 cm measured by ultrasound;
- •Local lab serum Cr >3.0 mg/dl (265.2μmol/l) on the day of randomization;
- •Reference vessel size <4 mm or >8 mm.
研究组 & 干预措施
Not stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is <0.80, randomization will be ignored, and stenting will be performed.
干预措施: Dopamine (Drug)
Not stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is <0.80, randomization will be ignored, and stenting will be performed.
干预措施: Fractional Flow Reserve, Renal (Diagnostic Test)
Not stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. If FFR is ≥0.80, randomization will be applied, and no stenting will be implanted. If FFR is <0.80, randomization will be ignored, and stenting will be performed.
干预措施: Renal artery stenting (Device)
Stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.
干预措施: Dopamine (Drug)
Stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.
干预措施: Fractional Flow Reserve, Renal (Diagnostic Test)
Stenting
Hyperemic FFR induced by 50μg/kg of dopamine via renal artery will be measured. No matter FFR is, stenting will be performed as planned.
干预措施: Renal artery stenting (Device)
结局指标
主要结局
Change in daytime mean systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: From baseline to 3 months post-procedure
Change in the composite index of antihypertensive drugs
时间窗: From baseline to 3 months post-procedure
Change in the composite index of antihypertensive drugs. Drug Composite Index = Weight (number of classes of antihypertensive drugs) × (sum of doses)
次要结局
- Change in diastolic blood pressure as measured by 24-hour ABPM(From baseline to 3 months post-procedure)
- Change in home blood pressure(From baseline to 3 months post-procedure)
- Change in the composite index of antihypertensive drugs to reach target blood pressure(From baseline to 1 year post-procedure)
- Acute myocardial infarction incidence(From baseline to 1 year post-procedure)
- Change in office blood pressure(From baseline to 3 months post-procedure)
- Change in systolic blood pressure as measured by 24-hour ABPM(From baseline to 3 months post-procedure)
- Change in ABPM(From baseline to 6 months, 1 year post-procedure)
- All-cause death(From baseline to 1 year post-procedure)
- Cardiac death(From baseline to 1 year post-procedure)
- Non-fatal stroke incidence(From baseline to 1 year post-procedure)
- Rehospitalization due to heart failure incidence(From baseline to 1 year post-procedure)
- Increase in serum creatinine or dialysis(From baseline to 1 year post-procedure)
研究者
Jianping LI
Professor
Peking University First Hospital