Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study)
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Purpose
Renal atherosclerotic stenosis (RAS) is a prevalent cause of secondary hypertension (HT). Since there are still uncertainties as to whether and in what patients revascularization by means of percutaneous renal angioplasty (PTRAS) should be pursued, we designed a study exploiting an optimized patient selection strategy and using hard experimental endpoints to unravel these uncertainties.
Primary objective: to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan.
Secondary objectives: to determine if the two treatments are equivalent in lowering blood pressure (BP), preserving overall renal function and regressing damage in the target organs of hypertension.
Design: prospective multicenter randomized, unblinded two-arm study.
Eligible patients will have clinical and/or radiological evidence of unilateral or bilateral RAS, defined by stenosis of the proximal portion of the renal artery and its main bifurcations at angioCT. Duplex scan will exclude nephroangiosclerosis as the latter could bias the assessment of the outcome of revascularization.
Inclusion criteria. RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation.
Renal function will be assessed with 99mTc-DTPA renal scintigraphy.
Sample size (30 patients per arm) was calculated to have a 90% power to detect a difference in means of GFR in the vascularized (or control untreated kidney) of 7.5 ml/min.
Arms
- Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.
- Medical therapy: the drug regimen that had been optimized during the run-in period.
Experimental endpoints:
The absolute value of GFR assessed by 99TcDTPA in the ischemic kidney will be used as quantitative variable and compared between groups at each time point. A categorical definition of kidney loss, defined as a GFR in the ischemic kidney of < 5 ml/min, will be also used and the rate of achievement of such endpoint will be compared.
Duration: 5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Artery Stenosis |
Drug: Optimal medical therapy Procedure: revascularization |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Endovascular Treatment Versus Optimal Medical Treatment of Atherosclerotic Renal Artery for Preserving Renal Function of the Ischemic Kidney. |
- Glomerular filtration rate in the ischemic kidney after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]The Primary Objective of the study is to determine if revascularization by means of PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate in the ischemic kidney as assessed by 99TcDTPA sequential renal scintiscan
- Lowering blood pressure after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. [ Time Frame: 1, 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]One secondary objective of the study is to determine if the two treatments (revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment) are equivalent in lowering blood pressure after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment.
- Preserving overall renal function after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. [ Time Frame: 1, 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]One secondary objective of the study is to determine if the two treatments (revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment) are equivalent in preserving overall renal function, as assessed by total estimated GFR, the reciprocal of serum creatinine, and indexes of Ca2+ and PO43- metabolism.
- Regression of damage in the target organs of hypertension, including cardiac hypertrophy, microalbuminuria and aortic stiffness after revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment. [ Time Frame: 1, 3, 6, 12, 24, 36, 48 and 60 months ] [ Designated as safety issue: Yes ]One secondary objective of the study is to determine if the two treatments (revascularization by means of percutaneous renal angioplasty (PTRAS) or optimal medical treatment) are equivalent in tregressing damage of the target organs of hypertension, including cardiac hypertrophy, microalbuminuria and aortic stiffness.
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: revascularization
The patients randomized to this treatment will undergo PTA with stenting of the renal artery.
|
Procedure: revascularization
The patients randomized to this treatment will undergo digital scan angiography (DSA) and PTA with stenting of the renal artery. PTA will be performed at the ostium or at truncular level. Stenoses involving more distal arterial vessels will be recorded and considered for data analysis but will not be treated. The patients randomized to revascularization will continue on their antihypertensive drug regimen. The dose and number of drugs will be down-titrated with the aim of pursuing the target BP values.
Other Name: Device: Palmaz Genesis stent on Cordis AMIIA delivery system
|
|
Active Comparator: medical therapy
The patients randomized to this treatment will undergo optimal medical therapy
|
Drug: Optimal medical therapy
Optimal medical therapy, including optimal antihypertensive therapy as defined by ESH/ESC Guidelines Mancia G. J Hypertens 2007; 25: 1105), antiplatelet and, if necessary, hypolipemic and hypoglycemic treatment. All patients will receive antiplatelet treatment with the same dose of aspirin (100 mg o.d.) or ticlopidine (250 mg b.i.d) if intolerant ASA, or clopidogrel (75 mg o.d.), if intolerant to ASA and ticlopidine, throughout the study period. LDL-cholesterol will be lowered to below 100 mg/dl, homocysteine if elevated will be lowered and treatment for diabetes will be optimized (HbA1c < 6.5%). |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- RAS affecting the main renal artery or its major branches at angio-CT either > 70% or, if < 70 with post-stenotic dilatation AND
- resistance index (RI) < 0.55 or > 0.55 but < 0.80 with evidence of intrarenal heterogeneity of the RI as revealed by a CV > 10% in the RI across the upper, mid and lower third of each kidney.
Exclusion Criteria:
- refusal to participate to study,
- previous endovascular or surgical treatment of RAS,
- fibromuscular RAS,
- planned or actual pregnancy, or childbearing potential without measures adequate to prevent pregnancy,
- life expectancy < 2 years,
- patient currently participating in another trial possibly influencing the safety of the patient and/or the outcomes of the study,
- co-morbid conditions limiting participation and follow-up.
Contacts and Locations| Contact: Gian Paolo Rossi, MD, FAHA | 0039 049 8213 ext 3304 | gianpaolo.rossi@unipd.it |
| Italy | |
| Dept. Clinical and Experimental Medicine, University of Padova, Italy | Not yet recruiting |
| Padova, Italy, 35128 | |
| Principal Investigator: Gian Paolo Rossi, MD, FACC | |
| Sub-Investigator: Diego Miotto, MD | |
| Sub-Investigator: Teresa M Seccia, MD, PhD | |
| Sub-Investigator: Raffaella Motta, MD | |
| Sub-Investigator: Matteo Vincenzi, MD | |
| Sub-Investigator: Gaetano Ramondo, MD | |
| Sub-Investigator: Pietro Zucchetta, MD | |
| Sub-Investigator: Diego Cecchin, MD | |
| Sub-Investigator: Franco Bui, MD | |
| Study Director: | Gian Paolo Rossi, MD, FACC | Dept Clinical and Experimental Medicine (DMCS), University Hospital of Padova, Italy |
More Information
Publications:
| Responsible Party: | Gian Paolo Rossi, University Hospital Padova |
| ClinicalTrials.gov Identifier: | NCT01208714 History of Changes |
| Other Study ID Numbers: | GPR-METRAS |
| Study First Received: | September 23, 2010 |
| Last Updated: | November 3, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University Hospital Padova:
|
Renal artery stenosis Atherosclerosis Arterial hypertension Percutaneous renal angioplasty Stenting |
Additional relevant MeSH terms:
|
Constriction, Pathologic Renal Artery Obstruction Pathological Conditions, Anatomical Kidney Diseases |
Urologic Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013