Renal Artery Fibromuscular DysplasiaDysArtNCT02586870
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment
A study testing Intravascular Ultrasound in people with Renal Artery Fibromuscular Dysplasia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Fibromuscular Dysplasia
- What is being tested?
- Intravascular Ultrasound
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to 2 Feb 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Renal Artery Fibromuscular Dysplasia
- Being tested
- Intravascular Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular UltrasoundDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
MAXIMAL VELOCITY
duplex ultrasound parameters
Measured: 24 months
ratio between maximal speed in the renal artery and in the aorta
duplex ultrasound parameters
Measured: 24 MONTHS
resistance index
duplex ultrasound parameters
Measured: 24 MONTHS
systolic ascension time
duplex ultrasound parameters
Measured: 24 MONTHS
Secondary outcomes (4)
stenosis length
MDCT anatomical parameters
Measured: 24 months
arterial diameter
MDCT anatomical parameters
Measured: 24 MONTHS
number of the stenosis
MDCT anatomical parameters
Measured: 24MONTHS
Distance Ostium / main stenosis
MDCT anatomical parameters
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Artery Fibromuscular DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- catherine GEINDRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586870
- Sponsor's protocol ID
- 2015-A01244-45
- Other IDs
- 2015-14
- Acronym
- DysArt
- Status last verified
- Aug 2022
- First submitted
- 22 Oct 2015
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34601043