Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811330

Enrollment

Registered

2008-12-19

Start date

2008-12-31

Completion date

2018-01-31

Last updated

2015-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Ventricular Hypertrophy

Keywords

Left ventricular hypertrophy, Aortic valve stenosis, Aortic valve replacement, Cardiopulmonary bypass, Statins, Myocardial preconditioning, Left ventricular reverse remodeling

Brief summary

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.

Interventions

DRUGAtorvastatin 80 mg

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

70 Years to 80 Years

Healthy volunteers

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

Exclusion criteria

* Ischemic heart disaese * Concomitant surgery to aortic valve replacement * Emergency surgery- Known intolerance for statin * Pregnant woman

Design outcomes

Primary

Measure	Time frame
♦ Phase I: To study changes on inflammatory markers after aortic valve replacement. ♦ Phase II: To study changes in left ventricular mass at the end of the study (12 months).	1 year

Secondary

Measure	Time frame
Phase I: To study changes on mitochondrial function, reactive oxygen species, and perioperative systolic and diastolic functions. Phase II: To study changes on clinical status, systolic and diastolic functions during the one-year follow-up.	1 year

Countries

France

Contacts

Primary ContactMichel KINDO, MD

michel.kindo@chru-strasbourg.fr33.3.69.55.08.11

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026