Heart Failure With Preserved Ejection FractionE-LUSNCT04644692
Effort-Lung Ultra Sound
An observational study of Heart Failure With Preserved Ejection Fraction, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Lung ultrasound
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 17 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients aged 65 years and older scheduled for a stress test.
Who may be able to join
- 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%)
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the detailed description
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.
- Being tested
- Lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundOther
A lung ultrasound before and at the end of the stress test.
| Study group | Role | What they receive |
|---|---|---|
| Case group: patients with heart failure with preserved ejection fraction | Not described Receives: 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. Receives: Other: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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.
Measured: 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
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.
Measured: 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
Measured: Within 10 minutes prior the start of the stress test
The modified Borg dyspnea score at rest, during exercise and during recovery.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start18 Jan 2021
- Primary completion21 Dec 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu ECHIVARD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644692
- Sponsor's protocol ID
- 2020PI156
- Acronym
- E-LUS
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2020
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.
- ClinicalTrials.gov ID
- NCT04644692
- Acronym / sponsor ID
- E-LUS / 2020PI156
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. | – | Other: Lung ultrasoundNon dyspnoeic patients with no history of Heart failure. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older scheduled for a stress test.
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundA lung ultrasound before and at the end of the stress test. | Other | Case group: patients with heart failure with preserved ejection fraction, Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure. |
Primary outcome
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
4 secondary outcomes
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
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
The B-lines score at rest measured by the 8-point method
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The exercise B-lines score measured by the 8-point method. (time frame: Within 2 minutes after the end of the stress test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.