Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150943
Status:
COMPLETED
Last Update Posted:
2006-04-27
First Post:
2005-09-06
Brief Title:
Stenting in Renal Dysfunction Caused by Atherosclerotic Renal Artery Stenosis
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
The Benefit of STent Placement and Blood Pressure and Lipid-Lowering for the Prevention of Progression of Renal Dysfunction Caused by Atherosclerotic Ostial Stenosis of the Renal Artery STAR
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Atherosclerotic renal artery stenosis ARAS is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly Current treatment includes restoration of the renal arterial lumen by endovascular stent placement However this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia ARAS patients have severe general vascular disease Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure Medical treatment focuses on the latter Lipidlowering drugs statins could reduce renal failure progression and could reduce the overall high cardiovascular risk The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown Therefore the STAR-study aims to compare the effects of renal artery stent placement together with medication vs medication alone on renal function in ARAS patients
Method
Patients with an ARAS of 50 and renal failure creatinine Cr clearance 80 mLmin173 m2 are randomly assigned to stent placement with medication or to medication alone Medication consists of statins anti-hypertensive drugs and antiplatelet therapy Patients are followed for 2 yrs with extended follow-up to 5 yrs The primary outcome of this study is a reduction in Cr clearance 20 compared to baseline This trial will include 140 patients
Atherosclerotic renal artery stenosis ARAS is associated with progressive loss of renal function and is one of the most important causes of renal failure in the elderly Current treatment includes restoration of the renal arterial lumen by endovascular stent placement However this treatment only affects damage caused by ARAS due to the stenosis and ensuing post-stenotic ischemia ARAS patients have severe general vascular disease Atherosclerosis and hypertension can also damage the kidney parenchyma causing renal failure Medical treatment focuses on the latter Lipidlowering drugs statins could reduce renal failure progression and could reduce the overall high cardiovascular risk The additional effect on preserving renal function of stent placement as compared to medical therapy alone is unknown Therefore the STAR-study aims to compare the effects of renal artery stent placement together with medication vs medication alone on renal function in ARAS patients
Method
Patients with an ARAS of 50 and renal failure creatinine Cr clearance 80 mLmin173 m2 are randomly assigned to stent placement with medication or to medication alone Medication consists of statins anti-hypertensive drugs and antiplatelet therapy Patients are followed for 2 yrs with extended follow-up to 5 yrs The primary outcome of this study is a reduction in Cr clearance 20 compared to baseline This trial will include 140 patients
Detailed Description:
This is a randomized multicenter trial of patients with an ostial ARAS and renal failure Patients will be randomized to
imedical treatment consisting of antihypertensive lipid-lowering and antiplatelet therapy plus the advice to stop smoking or iimedical treatment as outlined in i with additional stent placement
Patients with an ostial ARAS a Cr clearance of 80 mLmin173m2 according to the Cockcroft and Gault formula and stable blood pressure BP control are enrolled in this trial Ostial ARAS is defined as a luminal reduction of 50 of the renal artery within 1 cm of the aortic wall in the presence of atherosclerotic changes of the aorta Stenosis evaluation can be performed on CT-angiography MR angiography or intra-arterial angiography
Medical therapy Irrespective of baseline serum cholesterol values the patients will be treated with lipid-lowering therapy 10 mg of atorvastatin and if this is well tolerated the dose will be doubled to the final dose of 20 mg Any lipid-lowering medication currently used is discontinued and replaced by atorvastatin Hypertension is treated with the following drugs thiazide diuretic calcium antagonist beta-blocker and alpha-blocker ACE-inhibitorsangiotensin-II-antagonists together with increasing loop diuretic doses should be used only as a last resort antihypertensive treatment when other classes of antihypertensive agents have failed The target BP is 14090 mmHg Patients will receive anti-platelet therapy aspirin 75-100 mgod Considering that smoking is a major renal risk factor smokers will be advised to stop
Stent and medical therapy Medical therapy is identical in the two treatment arms In the stent group patients will start with aspirin 75-100 mgod the day before admission The stent Palmaz-Corinthian IQPalmaz Genesis Johnson Johnson Medical NVSA will be placed during an in-patient admission according to a standardized protocol
Randomisation will be done per participating centre and will be stratified for unilateral or bilateral abnormalities An unilateral abnormality is defined as an unilateral ostial stenosis and on the other side a normal renal artery or a truncal stenosis a truncal stenosis is nearly always easy to dilate by angioplasty All other patients are considered to have bilateral abnormalities
Clinical follow-up is scheduled after 1 3 and then every 3 months for the first 2 yrs and every 6 months until the 5 yr follow-up is completed Economic data are assessed after 3 mths and every 3 mths for 2 yrs Quality of life will be measured by standardized SF-36 and EQ-5D health questionnaires before after 1 mth and every 6 mths for 2 yrs
Indications for stent placement in the medically treated patients and re-angiography and balloon dilatation of the stent in the stented patients are i a persistent 20 reduction of Cr clearance ii therapy refractory hypertension defined as an office BP 180100 mmHg during three follow-up visits and subsequently a mean daily BP of 16095 mmHg on 24 hr ambulant BP monitoring while on the maximum dose of all classes of antihypertensives iii pulmonary edema in the presence of bilateral renovascular disease and a normal or slightly impaired left ventricular function on echocardiography in combination with ACE-inhibitorsangiotensin-II antagonist intolerance defined as a fall of estimated Cr clearance by 20 and iv malignant hypertension defined as fundus grade IIIIV
Analysis of results The difference in the proportion of patients with progressive renal dysfunction between both treatment arms will be assessed including 95 confidence intervals 95 CI Mean change and difference in renal function change including 95 CI will be reported With multivariate logistic regression analysis not only will the effects of the two treatment strategies be evaluated but also whether there are independent effects of age smoking proteinuria bilateral or unilateral renal artery stenosis BP and renal function at baseline
imedical treatment consisting of antihypertensive lipid-lowering and antiplatelet therapy plus the advice to stop smoking or iimedical treatment as outlined in i with additional stent placement
Patients with an ostial ARAS a Cr clearance of 80 mLmin173m2 according to the Cockcroft and Gault formula and stable blood pressure BP control are enrolled in this trial Ostial ARAS is defined as a luminal reduction of 50 of the renal artery within 1 cm of the aortic wall in the presence of atherosclerotic changes of the aorta Stenosis evaluation can be performed on CT-angiography MR angiography or intra-arterial angiography
Medical therapy Irrespective of baseline serum cholesterol values the patients will be treated with lipid-lowering therapy 10 mg of atorvastatin and if this is well tolerated the dose will be doubled to the final dose of 20 mg Any lipid-lowering medication currently used is discontinued and replaced by atorvastatin Hypertension is treated with the following drugs thiazide diuretic calcium antagonist beta-blocker and alpha-blocker ACE-inhibitorsangiotensin-II-antagonists together with increasing loop diuretic doses should be used only as a last resort antihypertensive treatment when other classes of antihypertensive agents have failed The target BP is 14090 mmHg Patients will receive anti-platelet therapy aspirin 75-100 mgod Considering that smoking is a major renal risk factor smokers will be advised to stop
Stent and medical therapy Medical therapy is identical in the two treatment arms In the stent group patients will start with aspirin 75-100 mgod the day before admission The stent Palmaz-Corinthian IQPalmaz Genesis Johnson Johnson Medical NVSA will be placed during an in-patient admission according to a standardized protocol
Randomisation will be done per participating centre and will be stratified for unilateral or bilateral abnormalities An unilateral abnormality is defined as an unilateral ostial stenosis and on the other side a normal renal artery or a truncal stenosis a truncal stenosis is nearly always easy to dilate by angioplasty All other patients are considered to have bilateral abnormalities
Clinical follow-up is scheduled after 1 3 and then every 3 months for the first 2 yrs and every 6 months until the 5 yr follow-up is completed Economic data are assessed after 3 mths and every 3 mths for 2 yrs Quality of life will be measured by standardized SF-36 and EQ-5D health questionnaires before after 1 mth and every 6 mths for 2 yrs
Indications for stent placement in the medically treated patients and re-angiography and balloon dilatation of the stent in the stented patients are i a persistent 20 reduction of Cr clearance ii therapy refractory hypertension defined as an office BP 180100 mmHg during three follow-up visits and subsequently a mean daily BP of 16095 mmHg on 24 hr ambulant BP monitoring while on the maximum dose of all classes of antihypertensives iii pulmonary edema in the presence of bilateral renovascular disease and a normal or slightly impaired left ventricular function on echocardiography in combination with ACE-inhibitorsangiotensin-II antagonist intolerance defined as a fall of estimated Cr clearance by 20 and iv malignant hypertension defined as fundus grade IIIIV
Analysis of results The difference in the proportion of patients with progressive renal dysfunction between both treatment arms will be assessed including 95 confidence intervals 95 CI Mean change and difference in renal function change including 95 CI will be reported With multivariate logistic regression analysis not only will the effects of the two treatment strategies be evaluated but also whether there are independent effects of age smoking proteinuria bilateral or unilateral renal artery stenosis BP and renal function at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C991810 | None | None | None |