Clinical trial NCT04644692: Effort-Lung Ultra Sound
Official title: Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years and older scheduled for a stress test.

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.

Eligibility 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

Primary outcomes:
measure: The exercise B-lines score measured by the 8-point method.
timeFrame: Within 2 minutes after the end of the stress test
Secondary outcomes:
measure: The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF).
timeFrame: Within 10 minutes prior the start of the stress test
measure: 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise
timeFrame: Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test
measure: The B-lines score at rest measured by the 8-point method
timeFrame: Within 10 minutes prior the start of the stress test
measure: The modified Borg dyspnea score at rest, during exercise and during recovery.
timeFrame: 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
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: