Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04644692
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2020-11-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effort-Lung Ultra Sound
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E-LUS
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: