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

Rennes University Hospital1 site in 1 country86 target enrollmentMay 11, 2016

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Rennes University Hospital
Enrollment: 86
Locations: 1
Primary Endpoint: Number of emergent hospitalization for any cardiovascular reason
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 11, 2016

End Date

January 6, 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Rennes University Hospital

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Number of emergent hospitalization for any cardiovascular reason

Time Frame: Month 12

Number of death of all cause

Time Frame: Month 12

Secondary Outcomes

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(Inclusion, 12 months)