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| ID | Type | Description | Link |
|---|---|---|---|
| 19/34844 | Other Identifier | Danish Data Protection Agency, Sourthern Denmark |
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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Region of Southern Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Classical low-flow low-gradient aortic stenosis | LVEF<50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. |
| |
| Paradoxical low-flow low-gradient aortic stenosis | LVEF>50% SVi < 35.0 mL/m2 Aortic mean gradient < 40 mmHg AVA < 1.0 cm2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dobutamine Stress Echocardiography | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects during Dobutamine infusion |
| Dobutamine infusion, up to 30 minutes |
| Factors associated with flow-reserve | a) Gender (male/female). | Dobutamine infusion, up to 30 minutes |
| Factors associated with flow-reserve | b) Aortic valve calcification assessed by cardiac CT (AU). | Dobutamine infusion, up to 30 minutes |
| Factors associated with flow-reserve | c) Myocardial fibrosis assessed by MRi (%). | 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). | Dobutamine infusion, up to 30 minutes |
| Factors associated with flow-reserve | e) The ongoing use of beta-blockers (%, dosis). | Dobutamine infusion, up to 30 minutes |
| Factors associated with flow-reserve |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with LFLG AS followed at the Department of Cardiology, Odense University Hospital will be offered participation in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nils Mogensen, MD | Contact | 61286371 | +45 | nils.sofus.borg.mogensen@rsyd.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | Fune | 5000 | Denmark |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D025401 | Echocardiography, Stress |
| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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f) Association with outcomes (rate of AVR, hospitalization for cardiac failure, death). |
| 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 | 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 | 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 | 1 day til 3 years |
| The ability of LDDE to predict outcome in patients with paradoxical low-flow, low-gradient aortic stenosis. | Cardiovascular mortality | 1 day til 3 years |
| D003933 | Diagnosis |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |