Chronic Kidney Disease Clinical Trial
Official title:
Phase 4 Study of Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing the Progression of Renal Failure in Atherosclerotic Renovascular Disease
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:
1. medical treatment with hypotensive drugs (all class of hypotensive agents will be used
according to single-center experience including drugs agent on
renin-angiotensin-aldosterone-system, when permitted), lipid lowering therapy (namely
all class of statins-or hydroxymethylglutaryl-coA reductase inhibitors)and
anti-platelet (acetylsalicylate and/or ticlopidine or clopidrogel according to
single-center experience) or to
2. the same medical therapy, as previously described in group a, associated with PTRS,
according to a standardized protocol, with a follow up at 2 years extended to other 2
years
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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