Effort-Lung Ultra Sound (E-LUS)

March 9, 2023 updated by: Mathieu ECHIVARD, Central Hospital, Nancy, France

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • CHRU de NANCY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Case group: patients with heart failure with preserved ejection fraction
Other: Lung ultrasound
A lung ultrasound before and at the end of the stress test.
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
A lung ultrasound before and at the end of the stress test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Within 2 minutes after the end of the stress test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
Time Frame: Within 10 minutes prior the start of the stress test
Within 10 minutes prior the start of the stress test
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020PI156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure With Preserved Ejection Fraction

Clinical Trials on Lung ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings