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: 1. To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF. 2. To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF. 3. To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF. 4. To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF. 5. To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF. 6. To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF. 7. To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF. 8. To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF. 9. To evaluate the correlation between the B-line score measured at rest and exercise and the dyspnoea score measured at rest, during exercise, and during the recovery phase. 10. To assess the correlation of the delta of B-lines scores between rest and exercise and the dyspnoea score measured at rest, during exercise and during the recovery phase.
Study Type
OBSERVATIONAL
Enrollment
56
A lung ultrasound before and at the end of the stress test.
CHRU de Nancy
Vandœuvre-lès-Nancy, France
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
Time frame: Within 2 minutes after the end of the stress test
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.
Time frame: Within 10 minutes prior the start of the stress test
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.
Time frame: 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
Time frame: 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.
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Time frame: 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