A Phase 2/3 interventional study of Hydrocortisone and Placebos in Atrial Fibrillation, sponsored by Kuopio University Hospital. Withdrawn at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Kuopio University Hospital · Phase 2/3, Interventional, and Prevention
The aim of the study is to intestigate whether three days intravenous corticosteroid management prevent atrial fibrillations in adults after mitral valve surgery. Prospective double-blinded randmized international multicenter study.
Voluntary adult patients, who do not have persistent atrial fibrillation before mitral valve sugery will receive either intravenous corticosteroid or placebo on three postoperative days after mitral valve surgery. End points are atrial fibrillation onset or fullfilling the three days time limit. The study is double-blinded, randomized, prospective study and the aim is to recruite 240 patients. Patients are recruited from Oulu University Hospital, Finland, Kuopio University Hospital, Finland, Helsinki University Hospital, Finland, Turku University Hospital, Finland, Tampere Univerisity Hospital, Finland, Tartu University Hospital, Estonia, Tallinn Regionaalhaigla, Estonia and Liverpool Hospital, Sydney, Australia.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
Browse Atrial Fibrillation studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
Drug: Hydrocortisone
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
Drug: Placebos
100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
Also known as: corticosteroid
100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
Also known as: placebo, saline
atrial fibrillation
Atrial fibrillation onset in the timeframe of three postoperative days after mitral valve surgery.
Time frame: three days after mitral valve surgery
Plan to share: No — IPD are not to be shared with other researchers.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital