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The E-LUS study is a prospective, non randomised, monocenter case-control study.
The main objective is to evaluate the association of exercise lung ultrasound data acquired during a stress test on a bicycle ergometer with the diagnosis of heart failure with preserved ejection fraction (HFpEF).
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group: patients with heart failure with preserved ejection fraction |
| ||
| Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure. | Non dyspnoeic patients with no history of Heart failure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung ultrasound | Other | A lung ultrasound before and at the end of the stress test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The exercise B-lines score measured by the 8-point method. | This score can have a value from 0 to 80, each anterior thoracic measurement point being rated from 0 to 10. A higher value indicate a higher level of pulmonary congestion. The measurement will be taken at the end of the stress test, in the first 2 minutes of recovery | Within 2 minutes after the end of the stress test |
| Measure | Description | Time Frame |
|---|---|---|
| The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF). | For secondary objectives 1, 2, 4, 5, 7 and 8, the endpoint will be the diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved LVEF. | Within 10 minutes prior the start of the stress test |
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Inclusion Criteria (Control group) :
Inclusion Criteria (Case group) :
Exclusion Criteria:
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Patients aged 65 years and older scheduled for a stress test.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
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| 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise | Regarding secondary objective 6, the judgment criterion will be the score of B-lines at rest measured by the 8-point method within 10 minutes prior the start of the stress test. This score can have a value from 0 to 80, each anterior thoracic measurement point being rated from 0 to 10. A higher value indicate a higher level of pulmonary congestion. | Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test |
| The B-lines score at rest measured by the 8-point method | Within 10 minutes prior the start of the stress test |
| The modified Borg dyspnea score at rest, during exercise and during recovery. | For secondary objectives 9 and 10, the endpoint will be the modified Borg dyspnea score at rest, during exercise and during recovery. This scale is ranging from 0 to 10, 10 indicating a maximal level of dyspnea. | Within 10 minutes prior the start of the stress test, at the peak of exercise and 3 minutes after the end of the stress test |