Left Atrial Volume Index in Asymptomatic Aortic Stenosis

NCT ID: NCT02395107

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Aortic Valve Stenosis; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nicolaj Lyhne Christensen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob E Møller, MD PhD DMsc

Role: STUDY_DIRECTOR

Odense University Hospital

Jordi S Dahl, MD PhD

Role: STUDY_CHAIR

Odense University Hospital

Lars M Videbæk, MD PhD

Role: STUDY_CHAIR

Odense University Hospital

Eva Søndergaard, MD PhD

Role: STUDY_CHAIR

Odense University Hospital

Locations

Odense University Hospital

Odense C, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 36356959 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33574022 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27894069 (View on PubMed)

Other Identifiers

S-20130067

Identifier Type: -

Identifier Source: org_study_id