An observational study in Aortic Valve Stenosis, Valvular Stenosis and Valvular Heart Disease, sponsored by Odense University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Odense University Hospital · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 150 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Odense University Hospital is the lead sponsor of 468 studies on the registry; 109 are open to participants now.
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Patients with LFLG AS followed at the Department of Cardiology, Odense University Hospital will be offered participation in the study.
Exclusion Criteria:
LVEF\<50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.
Diagnostic Test: Dobutamine Stress Echocardiography
LVEF\>50% SVi \< 35.0 mL/m2 Aortic mean gradient \< 40 mmHg AVA \< 1.0 cm2.
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.
Adverse effects during Dobutamine infusion
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).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
a) Gender (male/female).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
b) Aortic valve calcification assessed by cardiac CT (AU).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
c) Myocardial fibrosis assessed by MRi (%).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
d) Baseline myocardial systolic and diastolic function estimated by echocardiography (Global Longitudinal Strain (%), Strain Ratesystolic (SRs), deceleration time of mitral E-wave (ms) and end-systolic wall-stress corrected LVEF (dynes).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
e) The ongoing use of beta-blockers (%, dosis).
Time frame: Dobutamine infusion, up to 30 minutes
Factors associated with flow-reserve
f) Association with outcomes (rate of AVR, hospitalization for cardiac failure, death).
Time frame: Dobutamine infusion, up to 30 minutes
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Rate of AVR
Time frame: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Hospitalization for cardiac failure
Time frame: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
All-cause mortality
Time frame: 1 day til 3 years
The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis.
Cardiovascular mortality
Time frame: 1 day til 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Odense University Hospital