Left Atrial Volume Index in Asymptomatic Aortic Stenosis

NCT02395107 | Completed

• 1 other identifier: S-20130067
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  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.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe asymptomatic aortic stenosis.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (3)

• 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.

  PMID: 36356959 DERIVED

• 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.

  PMID: 33574022 DERIVED

• 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.

  PMID: 27894069 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Ventricular Outflow Obstruction; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Cardiomegaly

Study Officials

• Jacob E Møller, MD PhD DMsc

  Odense University Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

DK (1)