Hypertension Clinical Trial
Official title:
Optimum and Stepped Care Standardised Antihypertensive Treatment With or Without Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis. ANDORRA TRIAL
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.
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