The Second Prevention of Syncope Trial (POST II)—a randomized clinical trial of fludrocortisone for the prevention of neurally mediated syncope: Rationale and study design - 17/08/11
on behalf of the POST II Investigators1
Résumé |
Background |
Neurally mediated syncope is a common and frequently distressing problem. It is associated with a poor quality of life, which improves when the frequency of syncope is reduced. Few therapies for neurally mediated syncope have been proven effective. Fludrocortisone is commonly used to prevent recurrences of syncope but with little evidence to support its use. A placebo-controlled clinical trial of fludrocortisone for the prevention of neurally mediated syncope is needed.
Structure of Study |
POST II is a multicenter, international, randomized, placebo-controlled study of fludrocortisone in the prevention of neurally mediated syncope. The primary end point is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive fludrocortisone 0.05 to 0.2 mg or matching placebo and followed for 1 year. Secondary end points include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention-to-treat approach, with a secondary on-treatment analysis.
Power Calculations |
Assuming a 40% risk of syncope in the control arm, a relative reduction of 40% by fludrocortisone, and a dropout rate of 20%, the enrollment of 310 patients will give an 80% power of reaching a positive conclusion about fludrocortisone therapy, with P = .05.
Registration |
POST II is registered with both http:www.controlled-trials.com (ISRCTN 51802652) and http:www.clinicaltrials.gov (NCT00118482).
Implications |
This study will be the first adequately powered trial to determine whether fludrocortisone is effective in preventing neurally mediated syncope. If it is effective, then fludrocortisone may become the first-line medical therapy for this condition.
Le texte complet de cet article est disponible en PDF.Plan
This study is supported by a grant from the Canadian Institutes of Health Research, Ottawa, Canada, to RSS. Shire Pharmaceuticals, Toronto, Canada, provides the fludrocortisone and placebo tablets. SRR was supported by K12 and K23 (RR020783) grants from the National Institutes of Health, Bethesda, MD. |
Vol 151 - N° 6
P. 1186.e11-1186.e17 - juin 2006 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?