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OpenTrials
Completed

NCT Number: NCT00854698

Long-Term Effects of Aortic Valve Mismatch

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Strasbourg, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

subjects are asked to exercise 20 or 30 minutes.

subjects are asked to exercise during 20 or 30 minutes

Other

subjects are asked to exercise during 20 or 30 minutes

Primary outcomes

  1. variations in VO2 max during an effort

    Time frame: 1 year

Secondary outcomes

  1. Study the impact of a MVA after RVA by mechanical prosthesis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2009
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.