Effort-Lung Ultra Sound

  • STATUS
    Recruiting
  • End date
    May 23, 2023
  • participants needed
    90
  • sponsor
    Central Hospital, Nancy, France
Updated on 24 September 2021

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.

Details
Condition Heart Failure With Preserved Ejection Fraction
Treatment Lung ultrasound
Clinical Study IdentifierNCT04644692
SponsorCentral Hospital, Nancy, France
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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