Effort-Lung Ultra Sound
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Registration Number
- NCT04644692
- Lead Sponsor
- Central Hospital, Nancy, France
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Not provided
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The exercise B-lines score measured by the 8-point method. Within 2 minutes after the end 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. The measurement will be taken at the end of the stress test, in the first 2 minutes of recovery
- Secondary Outcome Measures
Name Time Method 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test 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.
The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF). Within 10 minutes prior the start of the stress test 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.
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. 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 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.
Trial Locations
- Locations (1)
CHRU de Nancy
🇫🇷Vandœuvre-lès-Nancy, France
CHRU de Nancy🇫🇷Vandœuvre-lès-Nancy, France