Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Rena… (NCT02539810) | Clinical Trial Compass
TerminatedPhase 4
Renal Artery Stenting in Patients With Documented Resistant Hypertension and Atherosclerotic Renal Artery Stenosis (ANDORRA)
France4 participantsStarted 2015-09
Plain-language 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%.
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 angiote…
What they're measuring
1
Mean change in diurnal systolic blood pressure assessed by ambulatory BP monitoring (ABPM)