Renal Artery StenosisPhase 3RASCADNCT01173666
Stenting of Renal Artery Stenosis in Coronary Artery Disease Study
A Phase 3 study testing stenting angioplasty plus medical therapy and Medical therapy in people with Renal Artery Stenosis and Left Ventricular Hypertrophy, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Artery Stenosis, Left Ventricular Hypertrophy
- What is being tested?
- stenting angioplasty plus medical therapy and Medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2006to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic heart disease
- angiographic diagnosis of atherosclerotic RAS >50% and ≤80%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiology Division, University of Catania, Azienda Policlinico-Vittorio Emanuele
Catania, 95100
Carmelita Marcantoni, M.D., 0039 095 726 3378, carmelita.marcantoni@gmail.com
Corrado Tamburino, M.D., 0039 095 743 6201, tambucor@unict.it
About this 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
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.
Read the 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.
- Being tested
- stenting angioplasty plus medical therapy, Medical therapy
- Keywords
- RAS, LVMI, Renal revascularization
- Medical subject headings
- Renal Artery Obstruction, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stenting angioplasty plus medical therapyProcedure or surgery
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.
Medical therapyDrug
Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.
| Study group | Role | What they receive |
|---|---|---|
| Drug therapy | Placebo comparator | Patients will be treated by standard medical therapy. Receives: Drug: Medical therapy |
| Drug therapy + stenting angioplasty | Experimental | Patients will be treated by standard medical therapy + stenting angioplasty of renal artery. Receives: Procedure: stenting angioplasty plus medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (2)
Cardiovascular mortality and morbidity
Measured: 5 years
Progression of renal function
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startApr 2006
- Primary completionApr 2011 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Investigators
- Carmelita Marcantoni, M.D., Principal investigator, Nephrology Division, Cannizzaro Hospital, Catania, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173666
- Sponsor's protocol ID
- RC-1
- Acronym
- RASCAD
- Status last verified
- Jul 2010
- First submitted
- 30 Jul 2010
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16049071Zeller 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.
PubMed 17488176Natale 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.
PubMed 35224730Marcantoni 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.
PubMed 22495466
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01173666
- Acronym / sponsor ID
- RASCAD / RC-1
- Keywords
- RAS, LVMI, Renal revascularization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio EmanueleUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Study start
- Apr 2006
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug therapy | Placebo comparator | Drug: Medical therapyPatients will be treated by standard medical therapy. |
| Drug therapy + stenting angioplasty | Experimental | Procedure: stenting angioplasty plus medical therapyPatients will be treated by standard medical therapy + stenting angioplasty of renal artery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ischemic heart disease
- angiographic diagnosis of atherosclerotic RAS >50% and ≤80%
Key exclusion criteria (6 listed)
- Atherosclerotic RAS>80%
- RAS secondary to fibromuscular dysplasia
- AMI
- single functioning kidney and/or sCr >4 mg/dl
- severe aortic valve stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stenting angioplasty plus medical therapyPatients 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. | Procedure or surgery | Drug therapy + stenting angioplasty |
| Medical therapyPatients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications. | Drug | Drug therapy |
Primary outcome
Left Ventricular Mass (LVMI, g/m2) changes
Time frame: 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).
2 secondary outcomes
Cardiovascular mortality and morbidity
Time frame: 5 years
Progression of renal function
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2010.
- Background: PubMed 16049071Wright 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.
- Background: PubMed 17488176Zeller 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.
- Derived from this study: PubMed 35224730Natale 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.
- Derived from this study: PubMed 22495466Marcantoni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelita Marcantoni, M.D. principal investigator
Nephrology Division, Cannizzaro Hospital, Catania, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stenting angioplasty plus medical therapy and Medical therapy in people with Renal Artery Stenosis and Left Ventricular Hypertrophy, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmelita Marcantoni, M.D. (0039 095 7263378, carmelita.marcantoni@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Mass (LVMI, g/m2) changes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01173666, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2010.