Long-Term Effects of Aortic Valve Mismatch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00854698
First received: March 2, 2009
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT
Other: exercise training
Other: subjects are asked to exercise during 20 or 30 minutes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Long-Term Effects of Aortic Valve Mismatch on Functional Ability and Remodeling the Left Ventricular After Aortic Valve Replacement Mechanics

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • variations in VO2 max during an effort [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Study the impact of a MVA after RVA by mechanical prosthesis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: June 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group with MVA Other: exercise training
subjects are asked to exercise 20 or 30 minutes.
group without MVA Other: subjects are asked to exercise during 20 or 30 minutes
subjects are asked to exercise during 20 or 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854698

Locations
France
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
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00854698     History of Changes
Other Study ID Numbers: 4199, 2008-A00663-52
Study First Received: March 2, 2009
Last Updated: June 20, 2014
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
THE LEFT VENTRICULAR REMODELING AFTER MECHANICAL AORTIC VALVE REPLACEMENT
exercise training

Additional relevant MeSH terms:
Ventricular Remodeling
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 01, 2014