Assessment Of Renal Artery Fibromuscular Dysplasia: From Diagnosis To Treatment. The Dysart Study

Objective: Define quantitative duplex ultrasound criteria and multidetector computed tomography (MDCT) for renal artery stenosis in fibromuscular dysplasia (FMD). Systemic arterial hypertension due to renal artery stenosis is a frequent complication of FMD and renal angioplasty effectively treats renal symptomatic FMD with a rate of hypertension cure of 36% with no consensus on the stenosis severity criteria in FMD. Primary Objective: Assessments of quantitative duplex ultrasound criteria to hemodynamically quantify renal artery stenosis severity in symptomatic FMD with trans stenotic pressure gradient measurements as standard of reference Design and method: Adults patients with confirmed hypertension in ambulatory BP 24H with renal artery multifocal FMD severe stenosis (defined using CT scan or duplex ultrasound), will be included in this study. Angiography with trans stenotic gradient will be performed. All patients will be recruited in a reference center for FMD care and included if clinical and para-clinical information suggest that the hypertension might be caused by the renal stenosis and will require intravascular revascularization in reference of the standard procedures in FMD. Considering a two-side 95% confidence interval, with a precision of 10%, it is necessary to include at least 43 patients. Our study associates 4 reference centers of the French network. Patients will be evaluated for a period of 7 month after angioplasty for an inclusion period of 2 years. Efficacy of angioplasty will be assessed during follow-up visit using several parameters: decrease of the resting gradient at rest, decrease of degree of stenosis on IVUS, renal function and systemic hypertension. Results: The results are expected in 2018. Conclusions: Primary end point of DYSART Study: Assessments of quantitative duplex ultrasound criteria to hemodynamically quantify renal artery stenosis severity in symptomatic FMD, with trans stenotic pressure gradient measurements at rest as standard of reference.