Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

Study Overview
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Brief Summary
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Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.

Official Title
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Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Electrocardiogram
* Device: 2D and 3D echocardiography
* Device: Dobutamine stress echocardiography
* Biological: Blood tests
* Device: Cardiac MRI
* Device: Cardiac scanner
* Other: 6-minutes walking test
* Other: Duke Activity Score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient from 45 to 90 years old Patient agreeing freely to participate in the study Aortic surface area suspected to be < 1 cm² or < 0.6 cms²/m² Low aortic gradient defined by a mean pressure gradient < 40 mmHg Aortic low flow defined by: a stroke volume indexed < 35 ml/m2 Any contra-indication for the realization of the MRI Exclusion Criteria: Heart rhythm disorders Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L) Presence of a concomitant valvular heart disease with stenosis or regurgitation > moderated Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with aortic valve stenosis<br>115 patients will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : An electrocardiogram 2D and 3D echocardiography Dobutamine stress echocardiography Blood tests : blood electrolytes, creatinine, hemoglobin, N-terminal pro-brain natriuretic peptide (NT-ProBNP), C reactive protein (CRP), soluble suppression of tumorigenicity-2 (ST-2) A cardiac MRI A cardiac scanner A 6-minutes walking test An evolution of the Duke Activity Score | Device: Electrocardiogram<br>* ECG at inclusion and M12<br>Device: 2D and 3D echocardiography<br>* 2D and 3D echocardiography at inclusion and M12<br>Device: Dobutamine stress echocardiography<br>* dobutamine stress echocardiography at inclusion<br>Biological: Blood tests<br>* Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12<br>Device: Cardiac MRI<br>* Cardiac MRI at inclusion<br>Device: Cardiac scanner<br>* Cardiac scanner at inclusion<br>Other: 6-minutes walking test<br>* 6-minutes walking test at inclusion and M12<br>Other: Duke Activity Score<br>* Duke Activity Score at inclusion and M12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death of all cause |  | Month 12 | 
| Number of emergent hospitalization for any cardiovascular reason |  | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death (all causes) |  | 12 months | 
| Emergency Cardiovascular hospitalization |  | 12 months | 
| Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography |  | Inclusion, 12 months | 
| Symptoms evolution | 6-minute walking test | Inclusion, 12 months | 
| Symptoms evolution | Duke Activity Score | Inclusion, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic valve stenosis, low flow, dobutamine stress echocardiography