Endovascular Treatment Versus Optimal Medical Treatment of Atherosclerotic Renal Artery for Preserving Renal Function of the Ischemic Kidney.
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glomerular filtration rate in the ischemic kidney after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.
研究概览
简要总结
Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.
Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.
Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.
Design: prospective multicenter randomized, unblinded two-arm study.
Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.
Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation.
Renal function will be assessed with 99mTc-DTPA renal scintigraphy.
Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.
Arms
- Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.
- Medical therapy: the drug regimen that had been optimized during the run-in period.
Experimental endpoints:
The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.
Duration: 5 years.
详细描述
Background Renal atherosclerotic stenosis (RAS) is an increasingly prevalent causes of secondary hypertension (HT), and is becoming one of the first causes of end-stage renal failure requiring renal replacement therapy in an aging population. Atherosclerotic RAS is associated with a high cardiovascular risk profile leading to a considerable excess rate of morbidity and mortality from stroke, coronary heart and peripheral vascular disease.
Recent advances in antihypertensive drug therapy and in intensive risk factor management prompted the undertaking of prospective randomized trials that compared percutaneous renal angioplasty (PTRAS) with medical therapy. Unexpectedly, these trials failed to show compelling benefits of revascularization when added to effective medical therapy. However, they had serious limitations, which raised a number of criticisms, and limited to weight of their conclusions. Hence, clinicians are still left with uncertainties as to whether and in what patients revascularization should be pursued.
It is conceivable that only a study design exploiting an optimized patient selection strategy and a use of hard experimental endpoints could resolve these uncertainties and thus lead to a better clinical management of the increasing population with atherosclerotic RAS.
Objectives. The primary objective of the METRAS study is to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99TcDTPA sequential renal scintiscan.
Secondary objectives (see appropriate section) will be to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation AND
- •resistance index (RI) < 0.55 or > 0.55 but < 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV > 10% in the RI across the upper, mid and lower third of each kidney.
排除标准
- •refusal to participate to study,
- •previous endovascular or surgical treatment of RAS,
- •fibromuscular RAS,
- •planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy,
- •life expectancy < 2 years,
- •patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
- •co-morbid conditions limiting participation and follow-up.
研究组 & 干预措施
revascularization
The patients randomized to this treatment will undergo PTA with stenting of the renal artery.
干预措施: revascularization (Procedure)
medical therapy
The patients randomized to this treatment will undergo optimal medical therapy
干预措施: Optimal medical therapy (Drug)
结局指标
主要结局
Glomerular filtration rate in the ischemic kidney after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.
时间窗: 24 months
The Primary Objective of the study is to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99TcDTPA sequential renal scintiscan
次要结局
- Lowering blood pressure after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.(1, 3, 6, 12, 24, 36, 48 and 60 months)
- Preserving overall renal function after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.(1, 3, 6, 12, 24, 36, 48 and 60 months)
- Regression of damage in the target organs of hypertension, including cardiac hypertrophy, microalbuminuria and aortic stiffness after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.(1, 3, 6, 12, 24, 36, 48 and 60 months)