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The aim of the study is to value, in patients with chronic kidney disease and hypertension, whether medical therapy plus interventional renal artery revascularization is superior to medical therapy alone for the treatment of hemodynamically significant (>70%) atherosclerotic renal artery stenosis, diagnosed by duplex doppler ultrasonography and confirmed by magnetic resonance angiography, in terms of avoidance of the progression of renal damage, control of hypertension and in reducing the cerebro and cardiovascular complications.
Atherosclerotic renovascular disease (ARVD), due to renal hypoperfusion caused by mono or bilateral renal artery stenosis (RAS), is a increasing cause of chronic kidney disease and many elderly patients start dialysis due to ARDVD. Moreover ARVD is frequently progressive and reduces life-expectancy more than other causes of end stage renal disease, with a mortality rate higher than in patients with stable angina, similar to that of patients operated for colon cancer.
Unfortunately, there is not a definite therapy to cure this disease, despite important advancements in both medical therapy and in interventional radiology. Aim of the study is to see whether percutaneous transluminal interventional radiology plus stenting (PTRS) of the renal artery offers more, in terms of both preventing the progression of renal failure and controlling the hypertension, compared with the medical therapy addressed to control hypertension, improve the dyslipidemic profile and optimise the platelet anti-aggregant therapy, following the most recent guidelines. The eligible patients will be centrally randomized to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B:PTRS | Experimental | B: the same medical therapy, as previously described in group A, associated with PTRS |
|
| A:medical therapy | Active Comparator | hypotensive drugs, statins and antiplatelet therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical treatment | Drug | hypotensive drugs, statins and anti-platelets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Death, Initiation of dialysis therapy or either serum creatinine increase more than 20% or reduction by > 20% in estimated clearance of creatinine (with MDRD formula) | 0.5, 1 and 2 years follow up plus extended 4 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressure values at 0.5, 1 and 2 yrs follow up, with an extended follow up after 2 yrs | 0.5, 1 and 2 years follow up plus extended 4 yrs | |
| Number of hypotensive drugs | 0.5, 1 and 2 years follow up plus extended 4 yrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Scarpioni | Divisione Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza, Italy | Principal Investigator |
| Emanuele Michieletti | U.O. Radiologia II "Guglielmo da Saliceto" Hospital, Piacenza | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Divisione di Nefrologia e Dialisi, "Guglielmo da Saliceto" Hospital, Azienda USL Piacenza | Piacenza | Piacenza | 29100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16245247 | Result | Scarpioni R, Michieletti E, Cristinelli L, Ugolotti U, Scolari F, Venturelli C, Cancarini G, Pecchini P, Malberti F, Maroldi R, Rozzi G, Olivetti L. Atherosclerotic renovascular disease: medical therapy versus medical therapy plus renal artery stenting in preventing renal failure progression: the rationale and study design of a prospective, multicenter and randomized trial (NITER). J Nephrol. 2005 Jul-Aug;18(4):423-8. |
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| PTRS |
| Procedure |
Percutaneous transluminal renal artery stenting. The same medical therapy, as in group A, plus PTRS |
|
| renal artery stent | Device | Non-drug intervention, percutaneous transluminal renal artery stent angioplasty |
|
| renal artery stent | Device | Adding the renal artery stenting (in group B) to the optimal medical therapy (as in group A) that includes hypotensive drugs, statins and antiplatelet therapy |
|
| Results of renal scintigraphy | 0.5, 1 and 2 years follow up plus extended 4 yrs |
| Incidence of complications due to interventional manoeuvres | 0.5, 1 and 2 years follow up plus extended 4 yrs |
| Changes in the incidence of vascular complications in extra-renal districts | 0.5, 1 and 2 years follow up plus extended 4 yrs |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D051436 | Renal Insufficiency, Chronic |
| D006978 | Hypertension, Renovascular |
| D012078 | Renal Artery Obstruction |
| D007676 | Kidney Failure, Chronic |
| D007674 | Kidney Diseases |
| D006973 | Hypertension |
| D051437 | Renal Insufficiency |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006977 | Hypertension, Renal |
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