Clinical trial NCT01173666: Stenting of Renal Artery Stenosis in Coronary Artery Disease Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Renal Artery Stenosis
Left Ventricular Hypertrophy
Keywords: RAS
LVMI
Renal revascularization
Lead sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2010-08-02
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricular Mass (LVMI, g/m2) changes
timeFrame: 1 year
Secondary outcomes:
measure: Cardiovascular mortality and morbidity
timeFrame: 5 years
measure: Progression of renal function
timeFrame: 5 years
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele
Study officials:
affiliation: Nephrology Division, Cannizzaro Hospital, Catania, Italy
name: Carmelita Marcantoni, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wright JR, Shurrab AE, Cooper A, Kalra PR, Foley RN, Kalra PA. Left ventricular morphology and function in patients with atherosclerotic renovascular disease. J Am Soc Nephrol. 2005 Sep;16(9):2746-53. doi: 10.1681/ASN.2005010043. Epub 2005 Jul 27.
citation: Zeller T, Rastan A, Schwarzwalder U, Muller C, Frank U, Burgelin K, Sixt S, Schwarz T, Noory E, Neumann FJ. Regression of left ventricular hypertrophy following stenting of renal artery stenosis. J Endovasc Ther. 2007 Apr;14(2):189-97. doi: 10.1177/152660280701400211.
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Marcantoni C, Zanoli L, Rastelli S, Tripepi G, Matalone M, Mangiafico S, Capodanno D, Scandura S, Di Landro D, Tamburino C, Zoccali C, Castellino P. Effect of renal artery stenting on left ventricular mass: a randomized clinical trial. Am J Kidney Dis. 2012 Jul;60(1):39-46. doi: 10.1053/j.ajkd.2012.01.022. Epub 2012 Apr 10.