Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
NCT ID: NCT02727504
Last Updated: 2020-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
86 participants
OBSERVATIONAL
2016-05-11
2020-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with aortic valve stenosis
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
Electrocardiogram
ECG at inclusion and M12
2D and 3D echocardiography
2D and 3D echocardiography at inclusion and M12
Dobutamine stress echocardiography
dobutamine stress echocardiography at inclusion
Blood tests
Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12
Cardiac MRI
Cardiac MRI at inclusion
Cardiac scanner
Cardiac scanner at inclusion
6-minutes walking test
6-minutes walking test at inclusion and M12
Duke Activity Score
Duke Activity Score at inclusion and M12
Interventions
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Electrocardiogram
ECG at inclusion and M12
2D and 3D echocardiography
2D and 3D echocardiography at inclusion and M12
Dobutamine stress echocardiography
dobutamine stress echocardiography at inclusion
Blood tests
Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12
Cardiac MRI
Cardiac MRI at inclusion
Cardiac scanner
Cardiac scanner at inclusion
6-minutes walking test
6-minutes walking test at inclusion and M12
Duke Activity Score
Duke Activity Score at inclusion and M12
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
90 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU de Rennes
Rennes, , France
Countries
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Other Identifiers
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35RC15_9884_LOWAS
Identifier Type: OTHER
Identifier Source: secondary_id
2015-A00896-43
Identifier Type: -
Identifier Source: org_study_id
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