Aortic Valve StenosisPhase 3NCT00811330
Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis
A Phase 3 study testing Atorvastatin 80 mg in people with Aortic Valve Stenosis and Ventricular Hypertrophy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 to 80 years
- Conditions the study is for
- Aortic Valve Stenosis, Ventricular Hypertrophy
- What is being tested?
- Atorvastatin 80 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Ischemic heart disaese
- Concomitant surgery to aortic valve replacement
- Emergency surgery- Known intolerance for statin
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Cardio-VasculaireHôpital Civil
Strasbourg, 67 091
Michel KINDO, MD, 33.3.69.55.08.11, michel.kindo@chru-strasbourg.fr
About this study
Official title: Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
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.
- Conditions
- Aortic Valve Stenosis, Ventricular Hypertrophy
- Being tested
- Atorvastatin 80 mg
- Keywords
- Left ventricular hypertrophy, Aortic valve stenosis, Aortic valve replacement, Cardiopulmonary bypass, Statins, Myocardial preconditioning, Left ventricular reverse remodeling
- Medical subject headings
- Aortic Valve Stenosis, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80 mgDrug
Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| 1: Atorvastatin 80 mg. | Experimental | Atorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. Receives: Drug: Atorvastatin 80 mg |
| 2: No Atrovastatine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
♦ 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).
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel KINDO, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811330
- Sponsor's protocol ID
- 3963
- Status last verified
- Jun 2015
- First submitted
- 17 Dec 2008
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Statin in Surgical Aortic Stenosis: From Myocardial Preconditioning to Ventricular Reverse Remodeling.
- ClinicalTrials.gov ID
- NCT00811330
- Acronym / sponsor ID
- 3963
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Atorvastatin 80 mg. | Experimental | Drug: Atorvastatin 80 mgAtorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. |
| 2: No Atrovastatine | No intervention | – |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Ischemic heart disaese
- Concomitant surgery to aortic valve replacement
- Emergency surgery- Known intolerance for statin
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 80 mgAtorvastatin 80 mg PO every day for one year. The treatment will start 4 weeks before aortic valve replacement. | Drug | 1: Atorvastatin 80 mg. |
Primary outcome
♦ 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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel KINDO, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin 80 mg in people with Aortic Valve Stenosis and Ventricular Hypertrophy, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel KINDO, MD (33.3.69.55.08.11, michel.kindo@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
♦ 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.