Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS

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

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

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