Angiotensin II Receptor Blockade in Vascular Ehlers Danlos Syndrome: a Double Blind, Randomized, Placebo Controlled, Multicenter Trial. (ARCADE)

NCT02597361 Phase 3 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	COMPLETED
Enrolment	61
Start date	2016-01
Completion	2020-02-19

Conditions

• Ehlers-Danlos Syndrome, Vascular Type

Interventions

• Irbesartan
• Placebo

Primary outcomes

• Cardiovascular morbidity and mortality — 2 years
  Total number of any non-fatal and fatal cardiovascular events or events related to vEDS
• Arterial lesions — 2 years
  number and severity of arterial lesions detected by CTA

Countries

France