Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Phase 3

Completed

• Conditions: Heart Valve Diseases
• Interventions: Drug: Atorvastatin

• Registration Number: NCT02084069
• Lead Sponsor: Urmia University of Medical Sciences

Brief Summary

The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-03-08
• Study First Submitted QC: 2014-03-08
• Study First Posted: 2014-03-11
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-01-21
• Results First Submitted QC: 2015-01-21
• Status Verified: 2015-02
• Results First Posted: 2015-02-04
• Last Update Submitted: 2015-02-13
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Greater than 25 y/o
• No occurrence of intra- or post-operative cardiopulmonary arrest
• Not consuming drugs affecting atrial rhythm
• Having sinus rhythm before surgery
• Lack of paroxysmal atrial fibrillation history
• Only undergo heart valve surgery
• Lack of considerable heart ischemia needed atorvastatin use
• Routine cares in ward, post-operative ward, and intensive care unit were done

Exclusion Criteria

• Lesser than 25 y/o
• History of atrial fibrillation
• History of taking anti-arrhythmic drugs
• History of implementing pacemakers
• Severe heart failure
• Renal failure
• Hepatic failure
• Severe pulmonary diseases
• Heart block or bradyarrhythmia
• Routine cares in ward, post-operative ward, and intensive care unit were not done
• Performing concomitant cardiac surgery except valve repair
• Having considerable heart ischemia needed atorvastatin use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Atorvastatin	Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation Incidence After Open Cardiac Valve Repair	Within 5 days after open cardiac valve repair

Trial Locations

Locations (1)

Seyyed-al-Shohada Heart Center; 🇮🇷 Urmia, West-Azerbaijan, Iran, Islamic Republic of