Long-Term Effects of Aortic Valve Mismatch

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT00854698
Collaborator
(none)
77
1
2
58
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exercise training
  • Other: subjects are asked to exercise during 20 or 30 minutes
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Apr 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group with MVA

Other: exercise training
subjects are asked to exercise 20 or 30 minutes.

Other: group without MVA

Other: subjects are asked to exercise during 20 or 30 minutes
subjects are asked to exercise during 20 or 30 minutes

Outcome Measures

Primary Outcome Measures

  1. variations in VO2 max during an effort [1 year]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU, Nouvel Hôpital Civil, Service de chirurgie cardio-vasculaire Strasbourg France

Sponsors and Collaborators

  • University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Petit-Eisenmann Hélène, MD, not affiliated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00854698
Other Study ID Numbers:
  • 4199
  • 2008-A00663-52
First Posted:
Mar 3, 2009
Last Update Posted:
Jun 23, 2014
Last Verified:
Jun 1, 2014
Keywords provided by University Hospital, Strasbourg, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2014