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

NCT ID: NCT05015829

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-08-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Classical low-flow low-gradient aortic stenosis

LVEF\<50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.

Dobutamine Stress Echocardiography

Intervention Type: DIAGNOSTIC_TEST

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

Paradoxical low-flow low-gradient aortic stenosis

LVEF\>50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.

Dobutamine Stress Echocardiography

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Low-flow (SVi<35 ml/m2) low-gradient (mean gradient <40 mmHg) AS with estimated AVA<1.0 cm2 referred to the Department of Cardiology, Odense University Hospital.

2. Age > 18 years.

3. Signed informed consent.

Exclusion Criteria

1. Other moderate-severe valvular heart disease.

2. Unwilling to participate in the study.

3. Poor echocardiographic window.

4. Inability to follow-up due to temporary citizenship Registration Number (CPR-Number) or emigration within the study period.

5. Pregnant women.

6. Patients with severe chronic renal failure (eGFR<40 ml/min) will not undergo cardiac MRi or CT angiography.

7. Known contrast allergy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern Denmark

OTHER

Sponsor Role: collaborator

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nils Sofus Borg Mogensen

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Odense University Hospital

Odense, Fune, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Nils Mogensen, MD

Role: CONTACT

nils.sofus.borg.mogensen@rsyd.dk

61286371 ext. +45

Facility Contacts

Nils Mogensen, MD

Role: primary

nils.sofus.borg.mogensen@rsyd.dk

61283671 ext. +45

Other Identifiers

19/34844

Identifier Type: OTHER

Identifier Source: secondary_id

S-20190058

Identifier Type: -

Identifier Source: org_study_id