Left Atrial Volume Index in Asymptomatic Aortic Stenosis (LAVIAS)

• ClinicalTrials.gov Identifier: NCT02395107
• Recruitment Status: Completed
• First Posted: March 20, 2015
• Last Update Posted: September 27, 2016
• Sponsor: Odense University Hospital
• Information provided by (Responsible Party): Nicolaj Lyhne Christensen, Odense University Hospital

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Blood

Eligibility Criteria

• 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.

Criteria

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.

Contacts and Locations

Locations

Denmark

Odense University Hospital

Odense C, Denmark, 5000

Sponsors and Collaborators

Odense University Hospital

Investigators

• 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Andersen MJ, Wolsk E, Bakkestrom R, Christensen N, Carter-Storch R, Omar M, Dahl JS, Frederiksen PH, Borlaug B, Gustafsson F, Hassager C, Moller JE. Pressure-flow responses to exercise in aortic stenosis, mitral regurgitation and diastolic dysfunction. Heart. 2022 Nov 10;108(23):1895-1903. doi: 10.1136/heartjnl-2022-321204.

Carter-Storch R, Mortensen NSB, Christensen NL, Ali M, Laursen KB, Pellikka PA, Moller JE, Dahl JS. First-phase ejection fraction: association with remodelling and outcome in aortic valve stenosis. Open Heart. 2021 Feb;8(1):e001543. doi: 10.1136/openhrt-2020-001543. Erratum In: Open Heart. 2021 Mar;8(1):

Christensen NL, Dahl JS, Carter-Storch R, Bakkestrom R, Jensen K, Steffensen FH, Sondergaard EV, Videbaek L, Moller JE. Association Between Left Atrial Dilatation and Invasive Hemodynamics at Rest and During Exercise in Asymptomatic Aortic Stenosis. Circ Cardiovasc Imaging. 2016 Oct;9(10):e005156. doi: 10.1161/CIRCIMAGING.116.005156.

• Responsible Party: Nicolaj Lyhne Christensen, MD, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02395107
• Other Study ID Numbers: S-20130067
• First Posted: March 20, 2015
• Last Update Posted: September 27, 2016
• Last Verified: September 2016

Keywords provided by Nicolaj Lyhne Christensen, Odense University Hospital:

Aortic Valve Stenosis; Functional Capacity; Cardiomyopathies; Endomyocardial Fibrosis; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Atrial Fibrillation; Hypertrophy; Hypertrophy, Left Ventricular; Diastology

Additional relevant MeSH terms:

Aortic Valve Stenosis; Constriction, Pathologic; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction