Effort-Lung Ultra Sound (E-LUS)

Central Hospital, Nancy, France

Status

Completed

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Other: Lung ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT04644692

2020PI156

Details and patient eligibility

About

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).

Full description

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.

Enrollment

56 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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