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

• Conditions: Aortic Valve Stenosis; Valvular Stenosis; Valvular Heart Disease
• Interventions: Diagnostic Test: Dobutamine Stress Echocardiography

• Registration Number: NCT05015829
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2021-07-15
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-20
• Last Update Posted: 2021-08-20
• Primary Completion: 2021-09-01
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Classical low-flow low-gradient aortic stenosis	Dobutamine Stress Echocardiography	LVEF\<50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.
Paradoxical low-flow low-gradient aortic stenosis	Dobutamine Stress Echocardiography	LVEF\>50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.

Primary Outcome Measures

Name	Time	Method
Factors associated with flow-reserve	Dobutamine infusion, up to 30 minutes	f) Association with outcomes (rate of AVR, hospitalization for cardiac failure, death).
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.	1 day til 3 years	Cardiovascular mortality
Adverse effects during Dobutamine infusion	Dobutamine infusion, up to 30 minutes	1. The occurrence of angina pectoris, severely high systolic blood pressure \>200 mmHg or ventricular premature beats Lown Grade \>3 or supra-ventricular arrhythmias or tachycardia assessed by ECG.; 2. Occurrence of signs of echocardiographic subvalvular obstruction; (systolic anterior motion of the mitral leaflet (SAM), high velocities (\>2 m/sec) in the LV outflow tract and late peaking systolic jet).

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Fune, Denmark