Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA) (ANDORRA)
Hypertension, Hypertension Resistant to Conventional Therapy, Angiographically Proven Grade III Unilateral or Bilateral Atherosclerotic Renal Artery Stenosis (ARAS) Greater Than or Equal to 60 Percent
About this trial
This is an interventional treatment trial for Hypertension
Eligibility 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
Sites / Locations
- Hopital Pasteur
- Hopital Saint Andre - CHU Bordeaux
- Hopital Rangueil - CHU Toulouse
- Hopital Lapeyronie - CHU Montpellier
- Hopital Arthur Gardiner
- Hopital Pontchaillou - CHU Rennes
- Groupe Hospitalier Mutualiste
- Hopital Michallon - CHU Grenoble
- Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
- Hopital de Brabois
- Hopital Cardiologique - CHRU Lille
- CHU Clermont-Ferrand
- Hopital de la Croix-Rousse - CHU Lyon
- Hopital de la Pitie Salpetriere
- Hopital Europeen Georges Pompidou (HEGP)
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Renal artery stenting
standardized and optimized medication regimen
Renal artery angioplasty plus stenting and standardized and optimized medication regimen. Patients are treated with renal artery stenting plus a standardized optimal medical treatment, including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
Patients are treated with a standardized optimal medical treatment including the antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.