Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2018-01-31

Brief Summary

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The purpose of the study is to see if statin therapy will optimize myocardial response to cardiopulmonary bypass during aortic valve replacement (AVR) for aortic valve stenosis (AVS) (Phase I) and optimize left ventricular reverse remodeling following AVR (Phase II). Preliminary evidence indicates that perioperative statin therapy reduce mortality and morbidity following cardiac surgery. Pleiotropic effects of statins may induce myocardial preconditioning and optimize myocardial and systemic responses to cardiopulmonary bypass during AVR. Furthermore statin therapy after AVR may contribute to an optimal left ventricular reverse remodeling.

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Detailed Description

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Conditions

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Aortic Valve Stenosis Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1: Atorvastatin 80 mg.

Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.

Group Type EXPERIMENTAL

Atorvastatin 80 mg

Intervention Type DRUG

Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.

2: No Atrovastatine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Atorvastatin 80 mg

Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> or = 70 years and \< 80 years
* Severe aortic valve stenosis
* Indication for aortic valve replacement by bioprothesis
* Ejection fraction \> or = 50%
* Without treatment with statin- No renal failure
* Informed consent signed