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%.
All eligible patients diagnosed with RH on office BP measurements and unilateral or bilateral ARAS ≥60% on a non-invasive test (CT-angiogram or MR-angiogram) will receive a standardized optimized triple antihypertensive treatment for 4 weeks. After 4 weeks, patients with confirmed RH by ABPM (daytime ABPM ≥ 135 or 85 mmHg) and no clinically significant increase in plasma creatinine from baseline (\< 30%) will undergo a renal angiogram to confirm the degree of ARAS ≥60% in diameter. Immediately after the renal angiography, all patients will undergo flow fractional reserve (FFR) measurements. Once FFR measurements have been done and all criteria are met, patients will be randomized in the angiography room to either renal artery stenting + SOMT (stenting group) versus SOMT (control group) whatever the results of the FFR in a 1:1 ratio. Both groups will continue the SOMT during follow-up. The SOMT will be prescribed from the inclusion visit until the 6 month-visit after randomization. After randomization, the antihypertensive treatment will be adapted according to the results of home BP (HBP) at monthly visits starting 2 months after randomization. After the 6-month visit, the antihypertensive treatment adaptation will be left at the discretion of the physician in charge of the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
renal artery stenting
Slow release indapamide 1.5 mg/d (or furosemide 40 mg/d if eGFR is \< 30 mL/min/1.73m²) + irbesartan 300 mg/d + amlodipine 10 mg/d + aspirin 75 mg/d (or clopidogrel 75 mg/d in case of allergy or gastrointestinal intolerance to aspirin) + atorvastatin 20 mg/d. After randomization, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d and spironolactone 12.5 to 25 mg/d, will be sequentially added from months two to five in both groups if home blood pressure remains more than or equal to 135/85 mm Hg.
Hopital Pasteur
Nice, Alpes-Maritimes, France
Hopital Saint Andre - CHU Bordeaux
Bordeaux, Gironde, France
Hopital Rangueil - CHU Toulouse
Toulouse, Haute-Garonne, France
Hopital Lapeyronie - CHU Montpellier
Montpellier, Herault, France
Hopital Arthur Gardiner
Dinard, Ille-et-Vilaine, France
Hopital Pontchaillou - CHU Rennes
Rennes, Ille-et-Vilaine, France
Groupe Hospitalier Mutualiste
Grenoble, Isere, France
Hopital Michallon - CHU Grenoble
La Tronche, Isere, France
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hopital de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
...and 5 more locations
Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM)
Time frame: Baseline to 6 months
Adverse events of renal artery stenting
Time frame: Baseline to 12 months
Change in average 24-hour and nighttime Systolic Blood Pressure by ABPM
Time frame: Baseline to 12 months
Change in average 24-hour, daytime and nighttime diastolic Blood Pressure by ABPM
Time frame: Baseline to 12 months
Change in Systolic/diastolic Blood Pressure by home blood pressure monitoring
Time frame: Baseline to 12 months
Change in office Systolic/diastolic Blood Pressure
Time frame: Baseline to 12 months
Antihypertensive medication score
Time frame: Baseline to 12 months
Detection of the drugs in urine by LC-MS/MS
Time frame: Baseline to 12 months
Renal artery restenosis in patients of the stenting group assessed by duplex ultrasound and/or renal CTA
Time frame: Baseline to 12 months
Adverse cardiovascular (CV) events
Time frame: Baseline to 12 months
Change in plasma creatinine and eGFR
Time frame: Baseline to 12 months
Clinical renal events: renal death, progressive renal insufficiency (i.e. need for dialysis), need for permanent renal replacement therapy, need of target vessel stenting in the SOMT group (number of crossovers)
Time frame: Baseline to 12 months
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