Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE) (NCT02597361) | Clinical Trial Compass
CompletedPhase 3
Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome (ARCADE)
France61 participantsStarted 2016-01
Plain-language summary
This study aims to verify the hypothesis that patients with Vascular Ehlers Danlos syndrome (vEDS) should benefit of the blockade of angiotensin (Ang) II noxious effects on their vasculature affected by a defect in type III collagen in addition to the effects celiprolol. This randomized, double blind, placebo controlled trial compares the administration of the Ang II type I receptor blocker (ARB) - irbesartan- to placebo over a 2-year period in vEDS patients with the main objective to reduce the incidence of both symptomatic and asymptomatic vascular events.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Patients with genetically-proven vEDS (presence of a pathogenic mutation at the COL3A1 gene);
* Age ≥18 years and \<70 years;
* Men and women with reliable contraception or negative beta-HCG at screening;
* Celiprolol at the optimal tolerated dose since at least 12 weeks;
* vEDS patient fully intolerant to celiprolol but not treated with any other drug active on the vascular system, except another beta-blocker;
* No compelling indication for ARB therapy (renal infarction, hypertension, proteinuric nephropathy, chronic heart failure, myocardial infarction, stroke);
* Estimated glomerular filtration rate (GFR) ≥ 30ml/min/1,73m2 (MDRD Formula);
* Normal or clinically acceptable 12-lead ECG;
* Written informed consent to participate in the study.
Exclusion Criteria:
General criteria
* Unlikely to co-operate in the study and/or poor compliance anticipated by the investigator, e.g., uncooperative attitude, inability to return for follow-up visit, and unlikelihood of completing the study;
* Participation in another interventional therapeutic study at the same time or within 3 months prior to the beginning of the present study;
* Participant not affiliated to the French social security;
* No written informed consent;
* Severe contrast media allergy, not amenable to pre-treatment Medical and therapeutic criteria
* History of previous symptomatic visceral complication (any CV event, pulmonary or digestive event) in the 3 months preceding the inclusion;
* Forma…