Left Ventricular Hypertrophy, Renal Artery Stenosis
Conditions
Keywords
RAS, LVMI, Renal revascularization
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREstenting angioplasty plus medical therapy
Patients will be treated by stenting angioplasty of renal artery plus medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according to clinical indications.
DRUGMedical therapy
Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.
Sponsors
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* ischemic heart disease * angiographic diagnosis of atherosclerotic RAS \>50% and ≤80%
Exclusion criteria
* Atherosclerotic RAS\>80% * RAS secondary to fibromuscular dysplasia * AMI * single functioning kidney and/or sCr \>4 mg/dl * severe aortic valve stenosis * aortic aneurism necessitating surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Mass (LVMI, g/m2) changes | 1 year | Intervention in patients with RAS was hypothesized to produce a reduction in LVMI in a range between 5 to 10 g/m2. By using a 2-sided 2-sample t-test, it was calculated that a sample size of 168 patients (84 in the revascularization arm and 84 in the medical management arm) provides a 80% power to detect as significant (p\<0.01) a difference of -4.0 g/m2 between patients in the revascularization arm (expected change in LVMI: -9.2 ± 7.9 g/m2) and those in the medical management arm (expected change in LVMI: -5.2 ± 5.9 g/m2). |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality and morbidity | 5 years |
| Progression of renal function | 5 years |
Countries
Italy
Contacts
Primary ContactCarmelita Marcantoni, M.D.
Backup ContactGiovanni Tripepi, PhD
Outcome results
None listed