Aortic Valve StenosisLAVIASNCT02395107
Left Atrial Volume Index in Asymptomatic Aortic Stenosis
An observational study of Aortic Valve Stenosis and Heart Failure, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Failure
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with severe asymptomatic aortic stenosis.
Who may be able to join
- Asymptomatic severe aortic stenosis (Vmax > 3.5 m/sec and aortic valve area < 1 cm2).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Left Atrial Volume Index - Impact on LV Remodeling, LV Function and Functional Capacity in Asymptomatic Aortic Valve Stenosis
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.
Read the 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
- Keywords
- Aortic Valve Stenosis, Functional Capacity, Cardiomyopathies, Endomyocardial Fibrosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Atrial Fibrillation, Hypertrophy, Hypertrophy, Left Ventricular, Diastology
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure, Cardiomyopathies, Endomyocardial Fibrosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolaj Lyhne Christensen, Odense University Hospital
- Investigators
- Jacob E Møller, MD PhD DMsc, Study director, Odense University HospitalJordi S Dahl, MD PhD, Study chair, Odense University HospitalLars M Videbæk, MD PhD, Study chair, Odense University HospitalEva Søndergaard, MD PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395107
- Sponsor's protocol ID
- S-20130067
- Acronym
- LAVIAS
- Status last verified
- Sep 2016
- First submitted
- 16 Mar 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali M, Frederiksen PH, Moller JE, Mogensen NSB, Chemnitz A, Haujir A, Poulsen MK, Ovrehus KA, Pibarot P, Pellikka PA, Clavel MA, Dahl JS. Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Circ Heart Fail. 2026 Apr;19(4):e012809. doi: 10.1161/CIRCHEARTFAILURE.125.012809. Epub 2026 Feb 23.
PubMed 41730521Andersen 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.
PubMed 36356959Carter-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.
PubMed 33574022Christensen 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.
PubMed 27894069
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Volume Index - Impact on LV Remodeling, LV Function and Functional Capacity in Asymptomatic Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT02395107
- Acronym / sponsor ID
- LAVIAS / S-20130067
- Conditions
- Aortic Valve Stenosis, Heart Failure
- Keywords
- Aortic Valve Stenosis, Functional Capacity, Cardiomyopathies, Endomyocardial Fibrosis, Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with severe asymptomatic aortic stenosis.
Key inclusion criteria (1 listed)
- Asymptomatic severe aortic stenosis (Vmax > 3.5 m/sec and aortic valve area < 1 cm2).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Derived from this study: PubMed 41730521Ali M, Frederiksen PH, Moller JE, Mogensen NSB, Chemnitz A, Haujir A, Poulsen MK, Ovrehus KA, Pibarot P, Pellikka PA, Clavel MA, Dahl JS. Invasive Hemodynamic Exercise Response in Hemodynamically Significant Aortic Stenosis With Preserved Left Ventricular Ejection Fraction. Circ Heart Fail. 2026 Apr;19(4):e012809. doi: 10.1161/CIRCHEARTFAILURE.125.012809. Epub 2026 Feb 23.
- Derived from this study: PubMed 36356959Andersen 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.
- Derived from this study: PubMed 33574022Carter-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.
- Derived from this study: PubMed 27894069Christensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob E Møller, MD PhD DMsc study director
Odense University Hospital
Jordi S Dahl, MD PhD study chair
Odense University Hospital
Lars M Videbæk, MD PhD study chair
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Heart Failure, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02395107, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.