Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04644692
Status:
COMPLETED
Last Update Posted:
2023-03-13
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effort-Lung Ultra Sound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-09', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The exercise B-lines score measured by the 8-point method.', 'timeFrame': 'Within 2 minutes after the end of the stress test', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF).', 'timeFrame': 'Within 10 minutes prior the start of the stress test', 'description': '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.'}, {'measure': '2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise', 'timeFrame': 'Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test', 'description': '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.'}, {'measure': 'The B-lines score at rest measured by the 8-point method', 'timeFrame': 'Within 10 minutes prior the start of the stress test'}, {'measure': 'The modified Borg dyspnea score at rest, during exercise and during recovery.', 'timeFrame': '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', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'The E-LUS study is a prospective, non randomised, monocenter case-control study.\n\nThe 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).', 'detailedDescription': 'Secondary objectives:\n\n1. To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF.\n2. To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF.\n3. To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF.\n4. To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF.\n5. To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF.\n6. To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF.\n7. To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF.\n8. To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF.\n9. 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.\n10. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 years and older scheduled for a stress test.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (Control group) :\n\n* Patients 65 years of age and older scheduled for a stress test.\n* Never diagnosed with either preserved or altered ejection fraction heart failure\n* Non-dyspneic (New York Heart Association class I)\n\nInclusion Criteria (Case group) :\n\n* Patients 65 years of age and older scheduled for a stress test.\n* Patients already diagnosed with HFpEF following hospitalization for heart failure (LVEF\\>50%)\n\nExclusion Criteria:\n\n* Patients who are opposed to participate to the research project / the use of their data,\n* Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images (e.g. pulmonary fibrosis, diffuse interstitial lung disease or lung cancer)\n* Patients with a history of thoracic surgery\n* Patients under legal protection measures (guardianship, curator, judicial safeguard),\n* Pregnant women, parturient women or nursing mothers,\n* Patients who are unable to express consent,\n* Persons deprived of their liberty by a judicial or administrative decision,\n* Persons subject to psychiatric care,\n* Patients discharged from hospital for a worsening heart failure hospitalization for less than 15 days'}, 'identificationModule': {'nctId': 'NCT04644692', 'acronym': 'E-LUS', 'briefTitle': 'Effort-Lung Ultra Sound', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.', 'orgStudyIdInfo': {'id': '2020PI156'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group: patients with heart failure with preserved ejection fraction', 'interventionNames': ['Other: Lung ultrasound']}, {'label': 'Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure.', 'description': 'Non dyspnoeic patients with no history of Heart failure.', 'interventionNames': ['Other: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'OTHER', 'description': 'A lung ultrasound before and at the end of the stress test.', 'armGroupLabels': ['Case group: patients with heart failure with preserved ejection fraction', 'Control Group:Never diagnosed with either preserved or altered ejection fraction heart failure.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Praticien hospitalier', 'investigatorFullName': 'Mathieu ECHIVARD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}