Rationale and design of the GISSI-Atrial Fibrillation Trial: a randomized, prospective, multicentre study on the use of valsartan, an angiotensin II AT1-receptor blocker, in the prevention of atrial fibrillation recurrence.

What Was Tested

Researchers studied Angiotensin II Type 1 Receptor Blockers in this randomized controlled trial publication.

A substudy will analyse the effect of valsartan on left atrial dimensions and on neurohormones.

The study population consists of patients with symptomatic atrial fibrillation (at least two electrocardiogram documented atrial fibrillation episodes in the previous 6 months or successful cardioversion in the last 2 weeks) with underlying cardiovascular diseases or comorbidities.

With approximately 100 centres participating in Italy, a total of 1402 patients are randomized in a 1: 1 ratio to receive valsartan or placebo.

Who Took Part

According to the abstract, 1402 patients were involved.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter and parallel-group study.

Because people in this Angiotensin II Type 1 Receptor Blockers study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Angiotensin II Type 1 Receptor Blockers study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Angiotensin II Type 1 Receptor Blockers group a baseline to be compared against.

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

What Was Measured

Topics PubMed links to this paper include Angiotensin II Type 1 Receptor Blockers, Atrial Fibrillation, Echocardiography, Italy, Recurrence, Tetrazoles and Valine.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Angiotensin II Type 1 Receptor Blockers in 1402 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 2006 (Journal of cardiovascular medicine (Hagerstown, Md.)), a journal based in United States.

More context: all human trials.