Effort-Lung Ultra Sound

Heart Failure With Preserved Ejection Fraction Clinical Trial

— E-LUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644692
• Other study ID #: 2020PI156
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: March 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 17, 2022
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Other:
• Lung ultrasound
A lung ultrasound before and at the end of the stress test.

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The B-lines score at rest measured by the 8-point method		Within 10 minutes prior the start of the stress test
Secondary	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