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Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS (FLOW-AS)

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ClinicalTrials.gov Identifier: NCT03617406
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Diagnostic Test: Volume Challenge Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Volume Challenge Added to Dobutamine Stress Echocardiography in the Diagnosis of Severe Low-Flow, Low-Gradient Aortic Stenosis
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
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.
Diagnostic Test: Volume Challenge
Addition volume challenge with passive leg raising method in LDDSE as well as administration of normal saline and dobutamine during TEE




Primary Outcome Measures :
  1. Diagnosis of true severe AS [ Time Frame: Measures taken during echocardiograph a few minutes after administration of VC ]
    Proportion of patients 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617406


Contacts
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Contact: Christian Seiler, MD +41 31 632 36 93 christian.seiler@insel.ch
Contact: Eric Buffle, MD +41 31 632 38 21 eric.buffle@insel.ch

Locations
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Switzerland
Bern University hospital Recruiting
Bern, Switzerland, 3010
Contact: Christian Seiler, MD    +41 31 632 36 93    christian.seiler@insel.ch   
Sub-Investigator: Stefano de Marchi, MD         
Sub-Investigator: Eric Buffle, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Christian Seiler, MD University Clinic for Cardiology, Inselspital, Bern
Study Chair: Stefano de Marchi, MD University Clinic for Cardiology, Inselspital, Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03617406     History of Changes
Other Study ID Numbers: 3635
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
Low - flow
Low - gradient
Low - dose dobutamine
Volume challenge
Echocardiography

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents