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Completed

NCT Number: NCT04644692

Effort-Lung Ultra Sound

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).

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

About this study

Secondary objectives:

  • To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF.
  • To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF.
  • To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF.
  • To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF.
  • To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF.
  • To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF.
  • To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF.
  • To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Control group) :

  • 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

Treatment and study plan

Lung ultrasound

Other

A lung ultrasound before and at the end of the stress test.

Primary outcomes

  1. The exercise B-lines score measured by the 8-point method.

    Time frame: 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 outcomes

  1. The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF).

    Time frame: 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.

  2. 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise

    Time frame: 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.

  3. The B-lines score at rest measured by the 8-point method

    Time frame: Within 10 minutes prior the start of the stress test

  4. The modified Borg dyspnea score at rest, during exercise and during recovery.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: E-LUS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 25, 2020
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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