- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586870
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment (DysArt)
August 12, 2022 updated by: Assistance Publique Hopitaux De Marseille
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MAXIMAL VELOCITY
Time Frame: 24 months
|
duplex ultrasound parameters
|
24 months
|
ratio between maximal speed in the renal artery and in the aorta
Time Frame: 24 MONTHS
|
duplex ultrasound parameters
|
24 MONTHS
|
resistance index
Time Frame: 24 MONTHS
|
duplex ultrasound parameters
|
24 MONTHS
|
systolic ascension time
Time Frame: 24 MONTHS
|
duplex ultrasound parameters
|
24 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stenosis length
Time Frame: 24 months
|
MDCT anatomical parameters
|
24 months
|
arterial diameter
Time Frame: 24 MONTHS
|
MDCT anatomical parameters
|
24 MONTHS
|
number of the stenosis
Time Frame: 24MONTHS
|
MDCT anatomical parameters
|
24MONTHS
|
Distance Ostium / main stenosis
Time Frame: 24 MONTHS
|
MDCT anatomical parameters
|
24 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
February 2, 2020
Study Completion (Actual)
February 2, 2020
Study Registration Dates
First Submitted
October 22, 2015
First Submitted That Met QC Criteria
October 26, 2015
First Posted (Estimate)
October 27, 2015
Study Record Updates
Last Update Posted (Actual)
August 16, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A01244-45
- 2015-14 (assistance publique hopitaux de marseille)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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