Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment

Renal Artery Fibromuscular Dysplasia Clinical Trial

— DysArt  

Official title:

Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586870
• Other study ID #: 2015-A01244-45
• Secondary ID: 2015-14
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2, 2020

Study information

• Verified date: August 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective multicenter study based on the validation of diagnostic criteria and predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia. This is considered as a rare disease and patients are usually treated in specialized centers involved in a national network. Marseille is a center specialized in FMD and a member of the network that is very active across the country. In order to rapidly recruit patients the investigators propose a multicenter study. All patients included will benefit from an invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral stenosis the investigators will randomly omit data from one side and consider the data from the contralateral artery for further analysis, to avoid statistical interdependency. Patients who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral but with one non significant stenosis based on duplex ultrasound European recommendations for atherosclerotic renal artery stenosis) will be included in the second part of the study. These patients will in addition benefit from a trans stenotic pressure assessment under vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal artery stenosis will not be included in the analysis to assess predictive criteria for treatment efficacy on hypertension, treatment of these patients will followed the current best clinical practice. These patients will be followed during 6 to 8 month to assess potential complication of the pressure assessment renal artery stenosis, but their data will be included to assess the value of FFR and IVUS to guide the procedure. Patients with unilateral stenosis will be followed up 6 month after angioplasty in order to assess hypertension and to look for potential complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 2, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• hypertension based on ambulatory BP 24H measurements (12h mean daytime BP =135 or 85 mmHg)

• renal artery stenosis due to multifocal FMD of the main renal artery or accessory artery with a diameter = 5mm (defined using CT scan or duplex ultrasound),

• if clinical and para-clinical information suggest that the hypertension might be caused by the renal stenosis and will require intravascular revascularization because of:

• Recent onset of hypertension

• Resistant hypertension (hypertension treated by 3 hypertensive drugs including one diuretic) based on ambulatory BP measurements (12h mean daytime BP =135 or 85 mmHg)

• Hypertension for patients with poor compliance to medications or medication side effects.

• Acute flash pulmonary edema

• Delayed onset of hypertension with a decrease in kidney size or recent onset of renal failure especially after a renin-angiotensin system blocker

Exclusion Criteria:

• Patients with other causes of secondary hypertension

• Patients with renal artery stenosis from other causes than FMD higher than 30%

• Patients with unifocal FMD or intimal FMD

• Multifocal FMD of an accessory renal artery with a diameter < than 5 mm.

• Patient with involvement of a collateral artery of the main renal artery

• Renal artery dissection

• Patients with creatinine clearance (MDRD) lower that 40ml/min/1.73m2.

• Patients with an aneurysm with a diameter more than twice the diameter of the concerned artery

• Patients without a social security number

• Pregnant patients

• Patients who refuse to participate in the study

• Patients for whom the invasive measure are not possible

Related Conditions & MeSH terms

• Fibromuscular Dysplasia
• Hyperplasia
• Renal Artery Fibromuscular Dysplasia

Intervention

Device:
• Intravascular Ultrasound

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAXIMAL VELOCITY	duplex ultrasound parameters	24 months
Primary	ratio between maximal speed in the renal artery and in the aorta	duplex ultrasound parameters	24 MONTHS
Primary	resistance index	duplex ultrasound parameters	24 MONTHS
Primary	systolic ascension time	duplex ultrasound parameters	24 MONTHS
Secondary	stenosis length	MDCT anatomical parameters	24 months
Secondary	arterial diameter	MDCT anatomical parameters	24 MONTHS
Secondary	number of the stenosis	MDCT anatomical parameters	24MONTHS
Secondary	Distance Ostium / main stenosis	MDCT anatomical parameters	24 MONTHS