Stenting of Renal Artery Stenosis in Coronary Artery Disease Study

Left Ventricular Hypertrophy Clinical Trial

— RASCAD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01173666
• Other study ID #: RC-1
• Status: Recruiting
• Phase: Phase 3
• First received: July 30, 2010
• Last updated: July 30, 2010
• Start date: April 2006
• Est. completion date: April 2011

Study information

• Verified date: July 2010
• Source: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
• Contact: Carmelita Marcantoni, M.D.
• Phone: 0039 095 7263378
• Email: carmelita.marcantoni[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy
• Myocardial Ischemia
• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Procedure:
• stenting 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.

Drug:
• Medical therapy
Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.

Locations

Country	Name	City	State
Italy	Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele	Catania

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele	Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Epub 2005 Jul 27. — View Citation

Zeller T, Rastan A, Schwarzwälder U, Müller C, Frank U, Bürgelin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Mass (LVMI, g/m2) changes	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).	1 year	Yes
Secondary	Cardiovascular mortality and morbidity		5 years	No
Secondary	Progression of renal function		5 years	No