Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment (DysArt)
Primary Purpose
Renal Artery Fibromuscular Dysplasia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intravascular Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Artery Fibromuscular Dysplasia
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Outcomes
Primary Outcome Measures
MAXIMAL VELOCITY
duplex ultrasound parameters
ratio between maximal speed in the renal artery and in the aorta
duplex ultrasound parameters
resistance index
duplex ultrasound parameters
systolic ascension time
duplex ultrasound parameters
Secondary Outcome Measures
stenosis length
MDCT anatomical parameters
arterial diameter
MDCT anatomical parameters
number of the stenosis
MDCT anatomical parameters
Distance Ostium / main stenosis
MDCT anatomical parameters
Full Information
NCT ID
NCT02586870
First Posted
October 22, 2015
Last Updated
August 12, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02586870
Brief Title
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment
Acronym
DysArt
Official Title
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
February 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Fibromuscular Dysplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Intravascular Ultrasound
Primary Outcome Measure Information:
Title
MAXIMAL VELOCITY
Description
duplex ultrasound parameters
Time Frame
24 months
Title
ratio between maximal speed in the renal artery and in the aorta
Description
duplex ultrasound parameters
Time Frame
24 MONTHS
Title
resistance index
Description
duplex ultrasound parameters
Time Frame
24 MONTHS
Title
systolic ascension time
Description
duplex ultrasound parameters
Time Frame
24 MONTHS
Secondary Outcome Measure Information:
Title
stenosis length
Description
MDCT anatomical parameters
Time Frame
24 months
Title
arterial diameter
Description
MDCT anatomical parameters
Time Frame
24 MONTHS
Title
number of the stenosis
Description
MDCT anatomical parameters
Time Frame
24MONTHS
Title
Distance Ostium / main stenosis
Description
MDCT anatomical parameters
Time Frame
24 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34601043
Citation
Cadour F, Silhol F, Iline N, Giorgi R, Lorthioir A, Amar L, Sapoval M, Rousseau H, Sarlon G, Thony F, Jacquier A. Insights from intravascular pressure measurement of renal artery revascularization in patients with fibromuscular dysplasia: The DYSART study. J Vasc Surg. 2022 Mar;75(3):939-949.e1. doi: 10.1016/j.jvs.2021.09.023. Epub 2021 Sep 30.
Results Reference
derived
Learn more about this trial
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment
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