Brief Title
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Official Title
Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Brief Summary
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.
Study Type
Observational
Primary Outcome
Number of death of all cause
Secondary Outcome
Death (all causes)
Condition
Aortic Valve Stenosis
Intervention
Electrocardiogram
Study Arms / Comparison Groups
Patient with aortic valve stenosis
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
86
Start Date
May 11, 2016
Completion Date
January 6, 2020
Primary Completion Date
January 6, 2020
Eligibility Criteria
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
Gender
All
Ages
45 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02727504
Organization ID
2015-A00896-43
Secondary IDs
35RC15_9884_LOWAS
Responsible Party
Sponsor
Study Sponsor
Rennes University Hospital
Study Sponsor
, ,
Verification Date
February 2020