NCT00811330

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

9.1 years

First QC Date

December 17, 2008

Last Update Submit

June 18, 2015

Conditions

Aortic Valve StenosisVentricular Hypertrophy

Keywords

Left ventricular hypertrophyAortic valve stenosisAortic valve replacementCardiopulmonary bypassStatinsMyocardial preconditioningLeft ventricular reverse remodeling

Outcome Measures

Primary Outcomes (1)

  • ♦ 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 Outcomes (1)

  • 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

Study Arms (2)

1: Atorvastatin 80 mg.

EXPERIMENTAL

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

Drug: Atorvastatin 80 mg

2: No Atrovastatine

NO INTERVENTION

Interventions

Atorvastatin 80 mgDRUG

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

1: Atorvastatin 80 mg.

Eligibility Criteria

Age70 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Cardio-VasculaireHôpital Civil

Strasbourg, 67 091, France

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisHypertrophy, Left Ventricular

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCardiomegalyHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Michel KINDO, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel KINDO, MD

CONTACT

33.3.69.55.08.11michel.kindo@chru-strasbourg.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 19, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

FR(1)