Effort-Lung Ultra Sound (E-LUS)

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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: Lung ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU de NANCY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years and older scheduled for a stress test.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group: patients with heart failure with preserved ejection fraction	Other: Lung ultrasound; A lung ultrasound before and at the end of the stress test.
Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure.; Non dyspnoeic patients with no history of Heart failure.	Other: Lung ultrasound; A lung ultrasound before and at the end of the stress test.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2020PI156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No