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Diagnostic Impact of Low-dose Dobutamine Echocardiography in Low-flow Low-gradient Aortic Stenosis

NCT05015829 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-08-20

No results posted yet for this study

Summary

When aortic valve-area is \<1.0cm2 and transvalvular mean-gradient is \>40mmHg, the diagnosis of severe aortic stenosis (AS) is straightforward. However, some patients present with an apparently reduced valve-area, despite transvalvular-gradient \<40mmHg; Low-flow, low-gradient aortic stenosis (LFLG AS). When a patient with LFLG AS also presents with LVEF \<50%, guidelines recommends performing a Low-Dose Dobutamine-echocardiography (LDDE) to confirm true-severe AS. However, nearly 30% of patients with LFLG AS do not show an adequate respond to Dobutamine. More commonly, patients present with the combination of LFLG AS, despite LVEF≥50%. In this group of patients the use of LDDE remains undisclosed.

The purpose of this study is to examine the safety and diagnostic usefulness of LDDE in patients with LFLG AS with LVEF≥50%. Furthermore we will examine factors associated with inadequate response to LDDE.

150 symptomatic and/or asymptomatic patients with LFLG and LVEF≥50% and a control group with LVEF\<50% will be enrolled at the Department of Cardiology, OUH. Patients will undergo clinical evaluation including LDDE, blood analyses, CT-scan and cardiac Mri.

Only a limited number of studies examine the possible use of LDDE in patients with LFLG AS and LVEF≥50% and no study has been performed documenting the safety and feasibility.

Conditions

  • Aortic Valve Stenosis
  • Valvular Stenosis
  • Valvular Heart Disease

Interventions

DIAGNOSTIC_TEST

Dobutamine Stress Echocardiography

Change in echocardiographic 2D and doppler measurements during infusion with Dobutamine 5 µg/kg/min till max dosage of 20 µg/kg/min.

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Region of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-09-01
Completion
2022-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05015829 on ClinicalTrials.gov