Left Ventricular Hypertrophy Clinical Trial
Official title:
Renal Artery Stenosis in Coronary Artery Disease: Medical Therapy Versus Medical Therapy Plus Renal Artery Stenting in Preventing Cardiac and Renal Outcomes. The Rationale and Study Design of a Prospective,Randomized Trial: the RASCAD Study
The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.
Patients with renal artery stenosis (RAS) have high frequency of alterations of left
ventricular mass and function. Whether renal revascularization can improve cardiac function
and structure in patients with RAS is not known.
The Stenting of Renal Artery Stenosis in Coronary Artery Disease (RASCAD) study was planned
to test whether renal artery revascularization, compared with medical therapy, affects left
ventricular hypertrophy progression and clinical outcomes in a high-risk population such as
patients with evidence of coronary artery disease and RAS.
Incidental patients affected by ischemic heart disease,undergoing cardiac catheterization at
a single institution, are also evaluated for the presence of RAS by renal angiography at the
end of coronarography. Patients with RAS >50% and ≤80% are randomly assigned to stenting
angioplasty plus medical therapy (angioplasty group) or to medical therapy alone (drug
therapy group)and followed up. Patients, randomly assigned to the angioplasty group, are
revascularized by stenting. All randomized patients receive antihypertensive, statin or
antiplatelet drugs according to clinical indications. The planned duration of follow-up is 5
years.
The health profile of patients is described in full at study entry. Cardiovascular events
(AMI, re-PTCA, cardiac heart failure, stroke,peripheral vascular disease),death,
hospitalizations and medications are carefully registered throughout the study.
Standard echocardiography and renal ultrasound studies are performed at baseline and
repeated every year. Echocardiography is performed following American Society of
Echocardiography guidelines. LV mass is estimated using the Devereux formula and indexed to
body surface area.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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