Effort-Lung Ultra Sound

Study Overview
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Brief Summary
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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).

Detailed Description
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Secondary objectives: To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF. To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF. To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF. To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF. To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF. To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF. To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF. To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF. 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. 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.

Official Title
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Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Other: Lung ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Control group) : Patients 65 years of age and older scheduled for a stress test. Never diagnosed with either preserved or altered ejection fraction heart failure Non-dyspneic (New York Heart Association class I) Inclusion Criteria (Case group) : Patients 65 years of age and older scheduled for a stress test. Patients already diagnosed with HFpEF following hospitalization for heart failure (LVEF>50%) Exclusion Criteria: Patients who are opposed to participate to the research project / the use of their data, Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images (e.g. pulmonary fibrosis, diffuse interstitial lung disease or lung cancer) Patients with a history of thoracic surgery Patients under legal protection measures (guardianship, curator, judicial safeguard), Pregnant women, parturient women or nursing mothers, Patients who are unable to express consent, Persons deprived of their liberty by a judicial or administrative decision, Persons subject to psychiatric care, Patients discharged from hospital for a worsening heart failure hospitalization for less than 15 days

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group: patients with heart failure with preserved ejection fraction<br> | Other: Lung ultrasound<br>* A lung ultrasound before and at the end of the stress test.<br>|
| Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure.<br>Non dyspnoeic patients with no history of Heart failure. | Other: Lung ultrasound<br>* A lung ultrasound before and at the end of the stress test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |