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Left Atrial Volume Index in Asymptomatic Aortic Stenosis (LAVIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02395107
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
Nicolaj Lyhne Christensen, Odense University Hospital

Brief Summary:

Aortic stenosis results in increased filling pressures of the heart. Size and function of the left atrium may be a marker for more advanced heart disease (heart failure) in patients with severe aortic stenosis, not presenting any apparent symptoms.

The goal of this study is to establish the importance and possible implications of left atrial dilation in asymptomatic patients with aortic valve stenosis.

Condition or disease
Aortic Valve Stenosis Heart Failure

Detailed Description:

Aortic valve stenosis (AS) is the most common valvular disease in the western world. Mild and moderate AS generally is well tolerated severe AS is associated with considerable morbidity and mortality.

The consequence of AS is increased pressure load on the left ventricle, which causes changes in the ventricular function and structure (Left ventricular remodeling, hypertrophy, fibrosis).

With longstanding elevated filling pressures the left atrium will dilate and heart failure symptoms will develop.

When apparent, symptoms of heart failure, in AS are associated with high mortality rate and aortic valve replacement (AVR) is recommended.

The clinical assessment of heart failure symptoms in AS is however challenging particularly in the elderly, as symptoms progress slowly and may mimic age related fragility.

In this observational study, the goal is to investigate the importance and possible implications of left atrial dilation and heart failure among 100 patients with asymptomatic severe aortic stenosis. Participants undergo echocardiographic evaluation for diastolic heart failure and we assess myocardial fibrosis using magnetic resonance imaging and exercise testing with invasive hemodynamic monitoring (right heart catheterization).

LA dilatation may potentially identify patients likely benefiting of early surgery. The importance and possible implications of LA dilatation in asymptomatic AS patients has however not yet been established.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Left Atrial Volume Index - Impact on LV Remodeling, LV Function and Functional Capacity in Asymptomatic Aortic Valve Stenosis
Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Primary Outcome Measures :
  1. Functional Capacity [ Time Frame: 2 years ]
    Differences in functional capacity reflected by atrial size. An incremental maximal exersice test to determine maximal whole-body oxygen uptake (VO2-max) will be performed. On a cycle ergometer VO2 and VCO2 are measured continuously with a breath-by-breath pulmonary exchange system. Following the warm up, the resistance is increased every 2 minutes for 3 bouts, where after the resistance increases every minute (10% increments in VO2-max). The test is terminated 30 seconds after the subjects are unable to maintain 60 revolutions pr. min, but are still able to bike. A horizontal plateau on the oxygen uptake graph demarks the maximal oxygen uptake in liters pr. min. This is divided by their body mass, to obtain maximal oxygen uptake pr. mass unit pr. time unit.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with severe asymptomatic aortic stenosis.

Inclusion Criteria:

  • Asymptomatic severe aortic stenosis (Vmax > 3.5 m/sec and aortic valve area < 1 cm2).

Exclusion Criteria:

  • Moderate LV systolic dysfunction (LVEF < 50%)
  • Concomitant moderate-severe aortic valve regurgitation
  • Concomitant moderate-severe mitral valve regurgitation
  • Moderate to severe nephropathy
  • Chronic or persistent atrial fibrillation
  • Implanted pacemaker or cardio defibrillator
  • Disability to exercise testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02395107

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Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Study Director: Jacob E Møller, MD PhD DMsc Odense University Hospital
Study Chair: Jordi S Dahl, MD PhD Odense University Hospital
Study Chair: Lars M Videbæk, MD PhD Odense University Hospital
Study Chair: Eva Søndergaard, MD PhD Odense University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nicolaj Lyhne Christensen, MD, Odense University Hospital Identifier: NCT02395107    
Other Study ID Numbers: S-20130067
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by Nicolaj Lyhne Christensen, Odense University Hospital:
Aortic Valve Stenosis
Functional Capacity
Endomyocardial Fibrosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Atrial Fibrillation
Hypertrophy, Left Ventricular
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction