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

Tracking Information

• First Submitted Date: March 16, 2015
• First Posted Date: March 20, 2015
• Last Update Posted Date: September 27, 2016
• Study Start Date: January 2014
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 20, 2015)

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.

Original Primary Outcome Measures (submitted: March 16, 2015)

Functional Capacity [ Time Frame: 2 years ]

Differences in functional capacity reflected by atrial size.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Blood

• Sampling Method: Non-Probability Sample
• Study Population: Adult patients with severe asymptomatic aortic stenosis.

Condition

• Aortic Valve Stenosis
• Heart Failure

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 16, 2015): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02395107
• Other Study ID Numbers: S-20130067
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nicolaj Lyhne Christensen, Odense University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Odense University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Odense University Hospital
• Verification Date: September 2016