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 range

18 Years – 70 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: * 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…

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

Cardiovascular morbidity and mortality

Timeframe: 2 years

Arterial lesions

Timeframe: 2 years

Trial details

NCT IDNCT02597361

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-19

View on ClinicalTrials.gov More Ehlers-Danlos Syndrome, Vascular Type trials