NCT04644692

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

November 12, 2020

Last Update Submit

March 9, 2023

Conditions

Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

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

    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

    Within 2 minutes after the end of the stress test

Secondary Outcomes (4)

  • 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

  • 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

  • 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

Study Arms (2)

Case group: patients with heart failure with preserved ejection fraction

Other: Lung ultrasound

Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure.

Non dyspnoeic patients with no history of Heart failure.

Other: Lung ultrasound

Interventions

Lung ultrasoundOTHER

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

Case group: patients with heart failure with preserved ejection fractionControl Group:Never diagnosed with either preserved or altered ejection fraction heart failure.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 65 years and older scheduled for a stress test.

You may qualify if:

  • 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)
  • Patients 65 years of age and older scheduled for a stress test.
  • Patients already diagnosed with HFpEF following hospitalization for heart failure (LVEF\>50%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Praticien hospitalier

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 25, 2020

Study Start

January 18, 2021

Primary Completion

December 21, 2021

Study Completion

May 17, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

FR(1)