Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment (NCT02586870) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment
France41 participantsStarted 2015-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MAXIMAL VELOCITY
Timeframe: 24 months
2
ratio between maximal speed in the renal artery and in the aorta