Long-Term Effects of Aortic Valve Mismatch

NCT ID: NCT00854698

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-04-30

Brief 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 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.

Conditions

THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group with MVA

Group Type: EXPERIMENTAL

exercise training

Intervention Type: OTHER

subjects are asked to exercise 20 or 30 minutes.

group without MVA

Group Type: OTHER

subjects are asked to exercise during 20 or 30 minutes

Intervention Type: OTHER

subjects are asked to exercise during 20 or 30 minutes

Interventions

exercise training

subjects are asked to exercise 20 or 30 minutes.

Intervention Type: OTHER

subjects are asked to exercise during 20 or 30 minutes

subjects are asked to exercise during 20 or 30 minutes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petit-Eisenmann Hélène, MD

Role: PRINCIPAL_INVESTIGATOR

not affiliated

Locations

CHRU, Nouvel Hôpital Civil, Service de chirurgie cardio-vasculaire

Strasbourg, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 27297001 (View on PubMed)

Other Identifiers

2008-A00663-52

Identifier Type: -

Identifier Source: secondary_id

4199

Identifier Type: -

Identifier Source: org_study_id