Brief Title
Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS
Official Title
Volume Challenge Added to Dobutamine Stress Echocardiography in the Diagnosis of Severe Low-Flow, Low-Gradient Aortic Stenosis
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.
Study Type
Interventional
Primary Outcome
Diagnosis of true severe AS
Condition
Aortic Valve Stenosis
Intervention
Volume Challenge
Study Arms / Comparison Groups
Arm Volume Challenge
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
50
Start Date
May 31, 2018
Completion Date
December 31, 2020
Primary Completion Date
December 31, 2020
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,
ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING STRESS ECHOCARDIOGRAPHY:
- 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
ADDITIONAL SPECIFIC EXCLUSION CRITERIA REGARDING TRANSESOPHAGEAL ECHOCARDIOGRAPHY:
- Oesophageal varices
- History of bariatric surgery
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christian Seiler, MD, +41 31 632 36 93, [email protected]
Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT03617406
Organization ID
3635
Responsible Party
Sponsor
Study Sponsor
University Hospital Inselspital, Berne
Study Sponsor
Christian Seiler, MD, Principal Investigator, University Clinic for Cardiology, Inselspital, Bern
Verification Date
March 2020