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

Rennes University Hospital

Status: Completed

Conditions: Aortic Valve Stenosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT02727504

2015-A00896-43

35RC15_9884_LOWAS (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 1 patient group

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

Treatment:

Other: 6-minutes walking test

Device: Cardiac scanner

Device: 2D and 3D echocardiography

Other: Duke Activity Score

Device: Electrocardiogram

Biological: Blood tests

Device: Cardiac MRI

Device: Dobutamine stress echocardiography