Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients - a Danish Nationwide Randomized Sham-Controlled Study.
概览
- 阶段
- 不适用
- 干预措施
- Renal artery stenting
- 疾病 / 适应症
- Renovascular Hypertension
- 发起方
- University of Aarhus
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Change in 24-hour ambulatory systolic blood pressure
- 状态
- 招募中
- 最后更新
- 9天前
概览
简要总结
The goal of this clinical trial is to document a beneficial effect of percutaneous transluminal renal angioplasty (PTRA) of atherosclerotic renal artery stenosis in high-risk patients selected according to the criteria used in the DAN-PTRA study. The main questions the trial aims to answer are if renal artery stenting compared with optimal medical treatment alone has beneficial effects on:
- Blood pressure
- Kidney function
- Hospitalizations for heart failure
详细描述
Even with optimal medical care, patients with renovascular disease have a very high risk of cardiovascular events and an expected poor outcome. One treatment option of atherosclerotic renal artery stenosis is percutaneous transluminal renal angioplasty with stent placement. Renal artery stenting is, however, still a subject of debate as randomized trials have failed to show a benefit of this compared with optimal medical treatment alone. Following the results of the large CORAL trial in 2014, we established the national prospective DAN-PTRA study using strict and well-defined criteria to select patients for renal artery stenting. In this study, we observed a reduction in blood pressure, an improved kidney function, and a decrease in new hospital admissions due to heart failure after renal artery stenting. The DAN-PTRAII study is a nationwide high-quality randomized, sham-controlled clinical trial in patients with severe renovascular disease due to atherosclerotic renal artery stenosis. Only patients who fulfill the inclusion criteria on optimal medical treatment can enter the study and only the operator and his team will know whether the patients receive renal artery stenting or sham treatment. Participants will be followed closely for 6 months after the treatment to evaluate the effects of renal artery stenting compared with optimal medical treatment alone on blood pressure, kidney function and hospitalizations due to heart failure.
研究者
入排标准
入选标准
- •One or more severe atherosclerotic renal artery stenoses defined as a stenosis ≥70% by catheter-based angiography.
- •In addition, at least one of the following high-risk clinical syndromes:
- •Resistant hypertension with average 24-hour ambulatory systolic blood pressure ≥150 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- •Rapidly declining kidney function with a reduction in estimated GFR of \>5 mL/min per 1.73m2 per year and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- •Hospital admissions with acute decompensated heart failure (≥2 hospitalizations for heart failure or ≥1 hospitalizations for sudden, "flash" pulmonary edema) with no obvious explanations such as nonadherence, left ventricular ejection fraction \<40%, or valvular heart disease and average 24-hour ambulatory systolic blood pressure ≥140 mmHg despite ≥3 antihypertensive drugs including a diuretic, if tolerated, and each prescribed at optimal doses.
- •All 24-hour ambulatory blood pressure monitorings are performed after nurse-administered medication.
排除标准
- •Unable to provide informed consent.
- •Treatment-resistant heart failure episodes presumed caused by renovascular disease.
- •Rapidly declining kidney function/acute kidney failure approaching the need for dialysis presumed caused by renovascular disease.
- •Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization.
- •Pregnancy or unknown pregnancy status in female of childbearing potential.
- •Kidney size \<7 cm (pole to pole length) supplied by target vessel.
- •Previous kidney transplant.
- •Previous PTRA treatment.
- •Presence of a renal artery stenosis not amenable for treatment with a stent.
- •Patients who are not eligible for randomization but treated with renal artery stenting outside the protocol are followed according to the DAN-PTRAII protocol in order to account for all PTRA treatments performed in Denmark in the study period.
研究组 & 干预措施
Renal artery stenting
Percutaneous transluminal renal angioplasty with stent placement
干预措施: Renal artery stenting
Renal artery stenting
Percutaneous transluminal renal angioplasty with stent placement
干预措施: Optimal medical therapy (OMT)
Renal artery stenting
Percutaneous transluminal renal angioplasty with stent placement
干预措施: Catheter-based angiography
Renal artery stenting
Percutaneous transluminal renal angioplasty with stent placement
干预措施: Measurement of translesional pressure gradients
Sham procedure
Sham procedure
干预措施: Optimal medical therapy (OMT)
Sham procedure
Sham procedure
干预措施: Catheter-based angiography
Sham procedure
Sham procedure
干预措施: Measurement of translesional pressure gradients
Sham procedure
Sham procedure
干预措施: Sham (No Treatment)
结局指标
主要结局
Change in 24-hour ambulatory systolic blood pressure
时间窗: Baseline and 6 months
Defined as the between-group difference in the change in 24-hour ambulatory systolic blood pressure from baseline to 6 months.
Change in 24-hour ambulatory systolic blood pressure.
时间窗: Baseline and 6 months.
Change in 24-hour ambulatory systolic blood pressure from baseline to 6 months after renal artery stenting compared with optimal medical therapy alone.
次要结局
- Change in estimated glomerular filtration rate (eGFR)(Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, 4.5 months, and 6 months)
- Change in attended automated office systolic blood pressure(Baseline, 3 months, and 6 months)
- Change in unattended automated office systolic blood pressure(Baseline, 3 months, and 6 months)
- Change in defined daily dose (DDD) of antihypertensive medications(Baseline, 3 months, and 6 months)
- Change in the number of antihypertensive medications(Baseline, 3 months, and 6 months)
- Change in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes)(Baseline, 3 months, and 6 months)
- Number of participants with cardiovascular or kidney outcomes(From baseline to 6 months after PTRA/sham)
- Number of deaths from any cause(From baseline to 6 months after PTRA/sham)
- Change in health status on 12-item Short Form Health Survey (SF-12)(Baseline, 3 months, and 6 months)
- Number of serious adverse events (SAEs), procedure-related adverse events (≤24 hours), and postoperative adverse events (>24 hours) occurring within 30 days after the procedure(From baseline to 30 days after PTRA/sham)
- Evaluation of Diagnostic Techniques(From baseline to 6 months after PTRA/sham)
- Change in kidney function.(Baseline, Day 1, Day 7, Day 21, 6 weeks, 3 months, and 6 months.)
- Changes in antihypertensive treatment.(Baseline, 3 months, and 6 months.)
- Change in 24-hour ambulatory systolic blood pressure (statistically adjusted for treatment changes).(Baseline, 3 months, and 6 months.)
- Number of participants with cardiovascular and kidney outcomes.(From baseline to 6 months after PTRA/sham.)
- Number of deaths from any cause.(From baseline to 6 months after PTRA/sham.)
- Health status on 12-Item Short Form Survey (SF-12).(Baseline, 3 months, and 6 months.)
- Number of serious adverse events (SAEs), procedure-related complications, and postoperative complications.(From baseline to 30 days after PTRA/sham.)
- Evaluation of Diagnostic Techniques.(From baseline to 6 months after PTRA/sham.)