Clinical trial NCT02395107: Left Atrial Volume Index in Asymptomatic Aortic Stenosis
Official title: Left Atrial Volume Index - Impact on LV Remodeling, LV Function and Functional Capacity in Asymptomatic Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Heart Failure
Keywords: Aortic Valve Stenosis
Functional Capacity
Cardiomyopathies
Endomyocardial Fibrosis
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Atrial Fibrillation
Hypertrophy
Hypertrophy, Left Ventricular
Diastology
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with severe asymptomatic aortic stenosis.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Functional Capacity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jacob E Møller, MD PhD DMsc
role: STUDY_DIRECTOR
affiliation: Odense University Hospital
name: Jordi S Dahl, MD PhD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Lars M Videbæk, MD PhD
role: STUDY_CHAIR
affiliation: Odense University Hospital
name: Eva Søndergaard, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.