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Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

Primary Purpose

Aortic Valve Stenosis, Ventricular Hypertrophy

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Atorvastatin 80 mg
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Left ventricular hypertrophy, Aortic valve stenosis, Aortic valve replacement, Cardiopulmonary bypass, Statins, Myocardial preconditioning, Left ventricular reverse remodeling

Eligibility Criteria

70 Years - 80 Years (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de Chirurgie Cardio-VasculaireHôpital CivilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1: Atorvastatin 80 mg.

2: No Atrovastatine

Arm Description

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

Outcomes

Primary Outcome Measures

♦ 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).

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2008
Last Updated
June 18, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT00811330
Brief Title
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
Official Title
Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Ventricular Hypertrophy
Keywords
Left ventricular hypertrophy, Aortic valve stenosis, Aortic valve replacement, Cardiopulmonary bypass, Statins, Myocardial preconditioning, Left ventricular reverse remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1: Atorvastatin 80 mg.
Arm Type
Experimental
Arm Description
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
Arm Title
2: No Atrovastatine
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80 mg
Intervention Description
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
Primary Outcome Measure Information:
Title
♦ 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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michel KINDO, MD
Phone
33.3.69.55.08.11
Email
michel.kindo@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel KINDO, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Cardio-VasculaireHôpital Civil
City
Strasbourg
ZIP/Postal Code
67 091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel KINDO, MD
Phone
33.3.69.55.08.11
Email
michel.kindo@chru-strasbourg.fr

12. IPD Sharing Statement

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Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis

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