THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENTNCT00854698
Long-Term Effects of Aortic Valve Mismatch
A study testing exercise training and subjects are asked to exercise during 20 or 30 minutes in people with THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The real impact of the existence of an aortic valve mismatch after aortic valve replacement in various studies conducted so far is a source of controversy. There is currently no long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling and its impact functional.To evaluate these… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT
- What is being tested?
- exercise training and subjects are asked to exercise during 20 or 30 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Apr 2014
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient major ≤ 60 years at the time of the aortic valve replacement.
- Patient affiliated with a social security
- Consent dated and signed by the investigator and the subject
- Subject having been informed of the results of the visit prior aortic valve replacement by mechanical prosthesis for pure aortic narrowing.
- Fraction left ventricular ejection ≥ 50%, when aortic valve replacement and at the time of inclusion.
- Aortic insufficiency at aortic valve replacement associated <II / IV.
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- aortic valve replacement exclusive (no gestures associated: coronary bypass, enlargement of the ring, another valve surgery,…).
- Coronarography normal at the aortic valve replacement.
- Normal renal function.
- No history of heart failure episode in the previous month inclusion.
- No indication against a stress test on bicycle ergometric
Who cannot join
- Refusal of the patient to be included in the study.
- History of cardiac surgery under extra body movement before and / or after the aortic valve replacement.
- Aortic insufficiency associated with the time of the transaction> II / IV.
- Chronic respiratory insufficiency.
- Track cancer or cancer evolving.
- Evolutionary Osteoarthritis of the lower limbs or widespread.
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- Myopathy device.
- Alteration higher making it impossible to carry out the test effort and response to the questionnaire on the quality of life.
- Coronaropathy documented.
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU, Nouvel Hôpital Civil, Service de chirurgie cardio-vasculaire
Strasbourg
About this study
Official title: Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics
The real impact of the existence of an aortic valve mismatch after aortic valve replacement in various studies conducted so far is a source of controversy. There is currently no long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling and its impact functional.To evaluate these effects of aortic valve mismatch on abilities to the effort, the quality of life and the regression of left ventricular hypertrophy long term after a aortic valve replacement, conducting a new study is fundamental. This study is even more essential in patients with a young life expectancy theoretical long and physical activity.Our study aims to determine whether the existence of an aortic valve mismatch has an influence on: The functional capacity to the effort by measuring the maximum oxygen consumption during a stress test (VO2 max) The reversal of left ventricular remodeling (cardiac ultrasound doppler), diastolic dysfunction (cardiac ultrasound and Doppler measurement Brain Natriuretic Peptide (BNP). This study will analyse these data in patients who received youth a VAN by mechanical aortic valve prosthesis.
- Being tested
- exercise training, subjects are asked to exercise during 20 or 30 minutes
- Keywords
- THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT, exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
subjects are asked to exercise 20 or 30 minutes.
subjects are asked to exercise during 20 or 30 minutesOther
subjects are asked to exercise during 20 or 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group with MVA | Experimental | Not described Receives: Other: exercise training |
| group without MVA | Other | Not described Receives: Other: subjects are asked to exercise during 20 or 30 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
variations in VO2 max during an effort
Measured: 1 year
Secondary outcomes (1)
Study the impact of a MVA after RVA by mechanical prosthesis
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 posted3 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENTStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petit-Eisenmann Hélène, MD, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854698
- Sponsor's protocol ID
- 4199
- Other IDs
- 2008-A00663-52
- Status last verified
- Dec 2025
- First submitted
- 2 Mar 2009
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Petit-Eisenmann H, Epailly E, Velten M, Radojevic J, Eisenmann B, Kremer H, Kindo M. Impact of Prosthesis-Patient Mismatch on Long-term Functional Capacity After Mechanical Aortic Valve Replacement. Can J Cardiol. 2016 Dec;32(12):1493-1499. doi: 10.1016/j.cjca.2016.02.076. Epub 2016 Mar 8.
PubMed 27297001
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics
- ClinicalTrials.gov ID
- NCT00854698
- Acronym / sponsor ID
- 4199
- Keywords
- THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT, exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 3 Mar 2009 (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 real impact of the existence of an aortic valve mismatch after aortic valve replacement in various studies conducted so far is a source of controversy. There is currently no long-term impact of the aortic valve mismatch on the reversal of left ventricular remodeling and its impact functional.To evaluate these effects of aortic valve mismatch on abilities to the effort, the quality of life and the regression of left ventricular hypertrophy long term after a aortic valve replacement, conducting a new study is fundamental. This study is even more essential in patients with a young life expectancy theoretical long and physical activity.Our study aims to determine whether the existence of an aortic valve mismatch has an influence on: The functional capacity to the effort by measuring the maximum oxygen consumption during a stress test (VO2 max) The reversal of left ventricular remodeling (cardiac ultrasound doppler), diastolic dysfunction (cardiac ultrasound and Doppler measurement Brain Natriuretic Peptide (BNP). This study will analyse these data in patients who received youth a VAN by mechanical aortic valve prosthesis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with MVA | Experimental | Other: exercise training |
| group without MVA | Other | Other: subjects are asked to exercise during 20 or 30 minutes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patient major ≤ 60 years at the time of the aortic valve replacement.
- Patient affiliated with a social security
- Consent dated and signed by the investigator and the subject
- Subject having been informed of the results of the visit prior aortic valve replacement by mechanical prosthesis for pure aortic narrowing.
- Fraction left ventricular ejection ≥ 50%, when aortic valve replacement and at the time of inclusion.
Key exclusion criteria (9 listed)
- Refusal of the patient to be included in the study.
- History of cardiac surgery under extra body movement before and / or after the aortic valve replacement.
- Aortic insufficiency associated with the time of the transaction> II / IV.
- Chronic respiratory insufficiency.
- Track cancer or cancer evolving.
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 |
|---|---|---|
| exercise trainingsubjects are asked to exercise 20 or 30 minutes. | Other | Group with MVA |
| subjects are asked to exercise during 20 or 30 minutessubjects are asked to exercise during 20 or 30 minutes | Other | group without MVA |
Primary outcome
variations in VO2 max during an effort
Time frame: 1 year
1 secondary outcome
Study the impact of a MVA after RVA by mechanical prosthesis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Results publication: PubMed 27297001Petit-Eisenmann H, Epailly E, Velten M, Radojevic J, Eisenmann B, Kremer H, Kindo M. Impact of Prosthesis-Patient Mismatch on Long-term Functional Capacity After Mechanical Aortic Valve Replacement. Can J Cardiol. 2016 Dec;32(12):1493-1499. doi: 10.1016/j.cjca.2016.02.076. Epub 2016 Mar 8.
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.
Petit-Eisenmann Hélène, MD principal investigator
not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training and subjects are asked to exercise during 20 or 30 minutes in people with THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT, 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 16 Dec 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variations in VO2 max during an effort (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00854698, which also lists 1 linked publication.
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 16 Dec 2025.