Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

NCT ID: NCT03617406

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2020-12-31

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.

Detailed 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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm Volume Challenge

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.

Group Type: OTHER

Volume Challenge

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Volume Challenge

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Seiler, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic for Cardiology, Inselspital, Bern

Stefano de Marchi, MD

Role: STUDY_CHAIR

University Clinic for Cardiology, Inselspital, Bern

Locations

Bern University hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

3635

Identifier Type: -

Identifier Source: org_study_id