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
| Type | Name | Description |
|---|---|---|
| OTHER | Lung ultrasound | A 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.