Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS (NCT03617406) | Clinical Trial Compass
CompletedNot Applicable
Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS
Switzerland50 participantsStarted 2018-05-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 REGAR…
What they're measuring
1
Diagnosis of true severe AS
Timeframe: Measures taken during echocardiograph a few minutes after administration of VC