Clinical trial NCT03617406: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Stenosis
Keywords: Low - flow
Low - gradient
Low - dose dobutamine
Volume challenge
Echocardiography
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Diagnosis of true severe AS
timeFrame: Measures taken during echocardiograph a few minutes after administration of VC
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University hospital
Study officials:
affiliation: University Clinic for Cardiology, Inselspital, Bern
name: Christian Seiler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinic for Cardiology, Inselspital, Bern
name: Stefano de Marchi, MD
role: STUDY_CHAIR
References: