Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS — FLOW-AS  

Aortic Valve Stenosis Clinical Trial

Official title: Volume Challenge Added to Dobutamine Stress Echocardiography in the Diagnosis of Severe Low-Flow, Low-Gradient Aortic Stenosis

Status Completed

Clinical Trial Summary

The aim of this study is to test the diagnostic added value of Volume Challenge (VC) to low-dose dobutamine stress echocardiography (LDDSE) in patients with a low-flow, low-gradient aortic stenosis (LFLGAS). This study will assess if LDDSE plus VC allows to increase the proportion of patients in whom a true severe AS can be differentiated from a pseudo severe AS.

Clinical Trial Description

The design of the study is a monocentric prospective non-randomized pilot clinical trial. A standard LDDSE will be performed. The stroke volume (SV) will be recorded. The addition of VC with the passive leg raise method at peak dobutamine dose will be performed. A transesophageal echocardiography (TEE) with low dose dobutamine and a bolus of normal saline will be performed as a validation method to measure AVA with the planimetry method. The SV will be recorded. Proportion of patient receiving the diagnosis of true severe AS defined as a combination of AVA <1.0 cm2 and ∆SV ≥ 20% will be compared between standard LDDSE and LDDSE with addition of VC. Calculating sensitivity, specificity, performing ROC curve analysis and calculating the Youden-index, the accuracy of the test method (LDDSE plus passive leg raising) for the detection of truly severe AS in comparison with the reference method (TEE) will be determined. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

• NCT number: NCT03617406
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Completion date: December 31, 2020