Heart Failure With Preserved Ejection Fraction
Conditions
Brief summary
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
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.
Interventions
OTHERLung ultrasound
A lung ultrasound before and at the end of the stress test.
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The exercise B-lines score measured by the 8-point method. | Within 2 minutes after the end 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. The measurement will be taken at the end of the stress test, in the first 2 minutes of recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF). | Within 10 minutes prior the start of the stress test | 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. |
| 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise | Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test | 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. |
| 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. | 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 | 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. |
Countries
France
Outcome results
None listed