Clinical Trials Directory

Trials / Completed

CompletedNCT04644692

Effort-Lung Ultra Sound

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

Status
Completed
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLung ultrasoundA lung ultrasound before and at the end of the stress test.

Timeline

Start date
2021-01-18
Primary completion
2021-12-21
Completion
2022-05-17
First posted
2020-11-25
Last updated
2023-03-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04644692. Inclusion in this directory is not an endorsement.