Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)

• Status: Terminated
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The ANDORRA study is a, multicenter, prospective, open, randomized, controlled blinded endpoint trial (PROBE) comparing two treatment strategies (renal artery stenting + standardized and optimized medical treatment [SOMT] versus SOMT alone) of 12 months duration in patients with confirmed resistant hypertension (RH) and angiographically proven grade III unilateral or bilateral atherosclerotic renal artery stenosis (ARAS) ≥ 60%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Antihypertensive Agents

Criteria

Inclusion Criteria:

• Age: 40 to 80 Years

• Men or women

• Supine office BP ≥ 140 and/or 90 mmHg at screening despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive treatments of different classes, including a diuretic.

• Unilateral or bilateral ARAS of a main renal artery ≥60% diagnosed by renal CT- angiogram (or MR-angiogram if there is a contraindication to perform CT) performed in the year before

• One or two functional kidney(s) ≥ 70 mm in pole-to-pole length

• eGFR ≥ 20 ml/min/1.73 m² (MDRD formula)

• Signed informed consent

• Social insurance coverage

Inclusion criteria for the renal angiogram procedure:

• RH confirmed by daytime ABPM ≥ 135 or 85 mmHg after 1 month treatment with SOMT at Visit V1.

Inclusion criteria for the randomization:

• Unilateral or bilateral ARAS of a main renal artery ≥ 60% confirmed on renal angiogram by Quantitative Vascular Analysis (QVA)

• Increase in plasma creatinine < 30% after 4-week SOMT

Exclusion Criteria:

• Fibromuscular dysplasia of renal artery or other non-atherosclerotic renal artery stenosis

• Other secondary form of hypertension excluded on the basis of a clinical, hormonological and/or imaging work-up

• Restenosis after a previous renal angioplasty or stenting

• Only a stenosis of an accessory renal artery supplying <1/2 of the ipsilateral renal parenchyma

• Additional indication of ARAS stenting (Malignant hypertension, ≥ 30% increase in plasma creatinine after renin angiotensin system (RAS) blocker or after RAS blocker and diuretic administration, flash pulmonary edema)

• Kidney pole-to-pole length < 70 mm

• Vascular disease precluding access for stenting

• Abrupt vessel closure or dissection after diagnostic angiography

• Contraindication to renal artery stenting according the notice for use of the stents

• eGFR < 20 ml/min/1.73 m² (MDRD)

• History of transient ischemic accident (TIA) or cerebrovascular accident (CVA) during the 3 months prior to visit 1

• History of acute heart failure or heart failure (NYHA class III-IV) within the 3 months prior to visit 1

• History of myocardial infarction, unstable angina, coronary bypass or percutaneous coronary angioplasty during the 3 months prior to visit 1

• Abdominal aortic aneurysm with indication for surgery or EVAR (Endovascular Aneurysm Repair)

• Known history of cholesterol embolism

• Brachial circumference of ≥ 42 cm

• Severe contrast media allergy, not amenable to pre-treatment

• Allergy to aspirin or clopidogrel

• Atrial fibrillation

• Comorbid condition causing life expectancy ≤ 3 years

• Unlikely to co-operate in the study and/or poor compliance anticipated by the investigator

• Participant not affiliated to the French social security

• Pregnancy or breastfeeding

• Guardianship for incapacity