Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome.

What Was Tested

This randomized controlled trial looks at Losartan.

The researchers aim to enroll a total of 300 patients aged > or =10 years who fulfil the Ghent criteria for Marfan syndrome.

Who Took Part

According to the abstract, 300 patients were involved.

This is a multicentre, randomized, placebo-controlled, double-blind, clinical trial with a 2-year inclusion period and a 3-year follow-up period.

Aortic root diameter will be measured using two-dimensional echocardiography.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and multicenter.

The patients were allocated by chance, so the Losartan group and the comparison group should start out alike.

As a double-blind Losartan study, the assignments were hidden from both participants and investigators until the end.

Some patients received a placebo instead of Losartan, giving a reference point.

More than one site took part, so the patients came from several places.

Analyses will be based on intention to treat.

What Was Measured

Topics PubMed links to this paper include Angiotensin II Type 1 Receptor Blockers, Aortic Aneurysm, Disease Models, Animal, France, Losartan, Marfan Syndrome and Mice.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Losartan in 300 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 1 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2010 (Archives of cardiovascular diseases), a journal based in Netherlands.

More context: all human trials.