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End of finantial support
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The purpose of this study is to evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | Patients treated with atorvastatin |
|
| Without Atorvastatin | Other | Patients treated without atorvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac surgery | Procedure | Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with postoperative atrial fibrillation(atorvastatin and control groups) | To evaluate the effectiveness of atorvastatin therapy (both during preoperative and postoperative period), as prophylaxis against postoperative atrial fibrillation after cardiac surgery, in a valve disease patient population (with or without associated coronary artery disease), with no previous history of atrial fibrillation and not receiving beta-blocking drugs or statins. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in inflammatory markers values during extracorporeal circulation, and postoperative atrial fibrillation. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. | |
| Changes in biochemical markers in both groups. |
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Inclusion Criteria:
Exclusion Criteria:
Urgent surgery.
Surgery due to endocarditis.
Patients with previous episodes of atrial fibrillation, although they are in sinus rhythm at hospital admission.
Treatment with beta-blockers at time of randomization
Severe left ventricular dysfunction with ventricular ejection fraction under 30%.
Chronic using of NSAIDs and / or corticosteroids at time of randomization
Uncontrolled thyroid disease.
Active liver disease and / or history of previous chronic liver disease.
Alcoholism.
Predisposing factors to statins adverse effects:
Known hypersensitivity to calcium atorvastatin and / or lactose monohydrate
In women of childbearing age, positive pregnancy test the day of inclusion in the study.
Not signed informed consent.
Inability to understand objectives of the study.
Exclusion criteria of the study once started:
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| Name | Affiliation | Role |
|---|---|---|
| Yolanda Carrascal Hinojal, M.D | Hospital ClÃnico Universitario de Valladolid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universitario de Valladolid | Valladolid | Valladolid | 47005 | Spain |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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| Cardiac surgery | Procedure | Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery |
|
| Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Changes in echocardiographic parameters in both groups. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Frequency, duration, characteristics and risk factors for postoperative atrial fibrillation in patients with valve disease (without history of previous arrhythmia) undergoing cardiac surgery. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Clinical and hemodynamic consequences of postoperative atrial fibrillation after cardiac surgery. | Participants will be followed for the duration of hospital stay, an expected average of 10 days. |
| Prolongation of in-hospital and Intensive Care Unit (ICU) stay and the need for new drug or interventionism therapies, directly related to its appearance. | Participants will be followed for the duration of hospital day, an expected average of 10 days. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |