Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS Study)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2010 by University Hospital Padova
Sponsor:
Information provided by:
University Hospital Padova
ClinicalTrials.gov Identifier:
NCT01208714
First received: September 23, 2010
Last updated: November 3, 2010
Last verified: September 2010
  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

  1. Revascularization: digital scan angiography and PTA with stenting of the renal artery at the ostium or at truncular level, plus optimal medical therapy.
  2. 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.

Resource links provided by NLM:


Further study details as provided by University Hospital Padova:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208714

Contacts
Contact: Gian Paolo Rossi, MD, FAHA 0039 049 8213 ext 3304 gianpaolo.rossi@unipd.it

Locations
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         
Sponsors and Collaborators
University Hospital Padova
Investigators
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 July 28, 2014