Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

NCT03617406 | Completed

• 1 other identifier: 3635
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Valve Stenosis

Keywords

Low - flow; Low - gradient; Low - dose dobutamine; Volume challenge; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Diagnosis of true severe AS

  Proportion of patients 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

  Measures taken during echocardiograph a few minutes after administration of VC

Study Arms (1)

Arm Volume Challenge

OTHER

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 TEE with low dose dobutamine and a bolus of normal saline will be performed as a validation method.

Diagnostic Test: Volume Challenge

Interventions

Volume Challenge DIAGNOSTIC_TEST

Addition volume challenge with passive leg raising method in LDDSE as well as administration of normal saline and dobutamine during TEE

Arm Volume Challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Written informed consent
• Patients with LFLGAS (mean Gradient: \< 40 mmHg, AVA ≤ 1.0 cm2 (by continuity equation using LVOT diameter) SVI ≤ 35 ml/m2), by rest TTE

You may not qualify if:

• Hypersensitivity to dobutamine or midazolam
• Lack of safe contraception defined as: Female participants of childbearing potential not using and not willing to continue contraception for study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.,
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Previous enrolment into the current study,
• Systolic left ventricular ejection fraction (LVEF) \< 20%
• More than mild aortic regurgitation
• Mitral valve disease, defined by mitral valve area \< 2.0 cm2 or more than mild mitral regurgitation
• Unstable angina
• Acute pulmonary oedema
• Signs of relevant left ventricular heart failure defined as crackles more than one fourth of lung field on auscultation
• Signs of relevant right ventricular heart failure defined as central venous pressure (CVP) \> 15 mmHg estimated with dilatation and collapsibility of vena cava inferior (VCI)
• Severe pulmonary, renal or hepatic disease
• Oesophageal varices
• History of bariatric surgery

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Christian Seiler, MD

  University Clinic for Cardiology, Inselspital, Bern

  PRINCIPAL INVESTIGATOR

• Stefano de Marchi, MD

  University Clinic for Cardiology, Inselspital, Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 6, 2018
• Study Start: May 31, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

CH (1)