Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT06602934
Status:
RECRUITING
Last Update Posted:
2025-01-17
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '6 months', 'description': 'Major adverse cardiovascular events (MACE) at 6 months'}, {'measure': 'Poor cardiorespiratory fitness', 'timeFrame': '30 months', 'description': 'Poor cardiorespiratory fitness at 30 months. Poor tolerance is a VO2max lower than normal values for age'}], 'secondaryOutcomes': [{'measure': 'Health care costs of CVRD progression after HAP', 'timeFrame': '18 months', 'description': 'Health care costs of CVRD progression after HAP over 18 months'}, {'measure': 'Rate of events', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rate of events : nonfatal stroke, nonfatal myocardial infarction, hospital admission for heart failure, and cardiovascular death'}, {'measure': 'Rate of thrombo-embolic events', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rates of thrombo-embolic events : pulmonary embolism, deep venous thrombosis'}, {'measure': 'Rates of CVD', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rates of CVD'}, {'measure': 'Rates of major respiratory events', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rates of major respiratory events are defined as COPD exacerbation, asthma exacerbation, hospitalization for respiratory failure, and respiratory-related mortality at 6 and 30 months'}, {'measure': 'NYHA (New York Heart Association) classification', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'NYHA (New York Heart Association) classification of dyspnea'}, {'measure': 'mMRC (Modified Medical Research Council) Dyspnoea Scale', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'mMRC (Modified Medical Research Council) Dyspnoea Scale (Grade O to 4 : grade O = I only get breathless with strenuous exercise ; grade 4 : I am too breathless to leave the house or I am breathless when dressing/undressing)'}, {'measure': 'Rate of restrictive chronic respiratory distress', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rate of restrictive chronic respiratory distress defined as% of patients withCPT (Total Lung Capacity) lower than normal values'}, {'measure': 'Rate of obstructive chronic respiratory distress progression', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rate of obstructive chronic respiratory distress progression'}, {'measure': 'Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex', 'timeFrame': 'Month 6 and Month 30', 'description': 'Percentage of patients with diffusion capacity for carbon monoxide (DLCO) lower than normal values for age and sex'}, {'measure': 'Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex', 'timeFrame': 'Month 6 and Month 30', 'description': 'Percentage of patients with vital capacity, expiratory reserve volume, and inspiratory reserved volume lower than normal values for age and sex'}, {'measure': 'Rate of patients with secondary lower respiratory tract infection', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rate of patients with secondary lower respiratory tract infection defined as clinical signs of infection with new infiltrate on Chest-X-Ray'}, {'measure': 'Rate of patients with non-respiratory infection', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rate of patients with non-respiratory infection'}, {'measure': 'Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27', 'timeFrame': 'Month 6 and Month 30', 'description': 'Rates of patients with the Montreal Cognitive Assessment (MoCA) score values lower than 27 at M6 and at M30'}, {'measure': 'Glasgow Outcome Scale Extended values', 'timeFrame': 'Month 6 and Month 30', 'description': 'Glasgow Outcome Scale Extended values to assess global disability and recovery after traumatic brain injury'}, {'measure': 'Brief Pain Inventory score', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'BPI score. This self-assessment questionnaire assesses the maind imensions of pain : intensity, functional disability, social and family repercussions and level of psychological distress (scale 0-10 : 0 = no pain , 10 = worst pain)'}, {'measure': 'Rates of patients with chronic pain', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'Rates of patients with chronic pain (yes/no) as defined as worse pain score value within the last 24 hours superior to 3'}, {'measure': 'Rates of patients with severe symptoms of anxiety', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'Rates of patients with severe symptoms of anxiety defined as HADS\\_A greater than or equal to 11'}, {'measure': 'Mean Satisfaction With Life Scale (SWLS) score', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': "Experience of CVRD progression from the patients' perspectives assessed by mean SWLS score"}, {'measure': 'Correlation between SWLS and EQ-5D-5L dimensions and utility scores', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'Correlation between Satisfaction With Life Scale (SWLS) and 5-level EQ-5D dimensions and utility scores'}, {'measure': 'SF(Short Form)-36 score', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': "Patients' responses to the SF-36 at months 6, 18 and 30 in order to estimate the change in Health-Related Quality of Life (HRQoL) over time"}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': "Patients' responses to the Fatigue Severity Scale at month 6, 18 and 30 in order to estimate change in perceived fatigue over time"}, {'measure': 'Mean QALYs (Quality-Adjusted Life-Years)', 'timeFrame': '30 months', 'description': 'Mean QALYs (Quality-Adjusted Life-Years) at 30 months'}, {'measure': 'EPICES (Evaluation of precariousness and health inequalities in health examination centers) score', 'timeFrame': 'Month 6, Month 18 and Month 30', 'description': 'Rate of socio-economical precarity defined as EPICES (Evaluation of precariousness and health inequalities in health examination centers) score values \\> 30 at M6, 18 and M30'}, {'measure': 'Modelisation of host-microbiome interactions', 'timeFrame': 'Month 0, Month 6, Month 18 and Month 30', 'description': 'Modelisation of host-microbiome interactions'}, {'measure': 'CVD progression', 'timeFrame': 'Month 6 and Month 30', 'description': 'CVD progression at Month 6 and Month 30'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hospital-acquired pneumonia', 'Cardiovascular and respiratory diseases', 'Respiratory microbiome'], 'conditions': ['Hospital Acquired Pneumonia (HAP)', 'Cardiovascular and Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'The HOMI-LUNG - HAP study is part of the HOMI-LUNG project, funded by the Horizon Europe program. The "HOMI-LUNG" project is an international, interdisciplinary project that aims to better understand the causal links between respiratory tract infections (i.e. pneumonia) and the progression of cardiovascular disease. More specifically, the project aims to quantify the burden of cardiovascular disease after pneumonia and assess patients\\' acceptability of long-term health alterations, as well as to define pneumonia endotypes with distinct pathobiological mechanisms associated with exacerbation of cardiovascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGroup A (patients with acute cardiac disease)\n\n* Male or female\n* Age ≥ 40years old\n* Hospitalized for acute coronary syndrome for less than 7 days.\n* Informed consent from the patient\n* Person insured under a health insurance scheme\n\nGroup B (patients with chronic cardiovascular disease)\n\n* Male or female,\n* Age ≥ 40 years old\n* Undergoing coronary artery by-pass surgery\n* Hospitalized in intensive care unit for \\> 12 hours\n* Informed consent from the patient\n* Person insured under a health insurance scheme\n\nGroup C (patients at risk of CVRD without chronic cardiovascular disease)\n\n* Male or female,\n* Age ≥ 40 years old\n* Familial high levels of cholesterol or triglycerides\n* With no personal history of CVRD, with a recent negative cardiac exercise test (last test inferior to 12 months)\n* Follow-up for lipid abnormalities at high risk of CVRD events\n* Informed consent from the patient\n* Person insured under a health insurance scheme\n\nGroup D (patients with HAP)\n\n* Male or female\n* Age ≥ 40years old\n* With one or more risk factors for CVD among:\n\nsmoking, abnormal lipidic levels, high blood pressure, obesity, diabetes mellitus, chronic kidney disease\n\n* Cured from mechanically ventilated HAP during the current hospitalization\n* Informed consent from the patient or relatives\n* Person insured under a health insurance scheme\n\nExclusion Criteria:\n\n* o Groups A, B, C and D\n* Age \\>80 years old\n* Immunosuppression pre-existing to the index hospitalisation, defined as lymphopenia \\< 500 elements/mm3, haematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug.\n* Pregnant women, breastfeeding women.\n* Adults under guardianship or trusteeship.\n* Low probability of survival at day 28.\n\n o Groups A, B, C\n* Community-acquired pneumonia or Hospital-acquired pneumonia within the last year.'}, 'identificationModule': {'nctId': 'NCT06602934', 'acronym': 'HOMI-LUNG-HAP', 'briefTitle': 'Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia - the HOMI-LUNG Project - Hospital-Acquired-Pneumonia', 'orgStudyIdInfo': {'id': 'RC24_0112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A : Patients with acute major cardiovascular event', 'description': 'Comparator', 'interventionNames': ['Other: Blood samples', 'Other: Oropharyngeal swabs', 'Other: Calcium score (CT scan)', 'Other: ECG', 'Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test']}, {'type': 'OTHER', 'label': 'Group B: Patients with severe chronic cardiovascular disease', 'description': 'Comparator', 'interventionNames': ['Other: Blood samples', 'Other: Oropharyngeal swabs', 'Other: Calcium score (CT scan)', 'Other: ECG', 'Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test']}, {'type': 'OTHER', 'label': 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'description': 'Comparator', 'interventionNames': ['Other: Blood samples', 'Other: Oropharyngeal swabs', 'Other: Calcium score (CT scan)', 'Other: ECG', 'Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test']}, {'type': 'EXPERIMENTAL', 'label': 'Group D: Patients cured of HAP', 'interventionNames': ['Other: Blood samples', 'Other: Oropharyngeal swabs', 'Other: Calcium score (CT scan)', 'Other: ECG', 'Other: Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test']}], 'interventions': [{'name': 'Blood samples', 'type': 'OTHER', 'description': 'Four blood samples will be taken outside standard care for groups A, B, C and D: at inclusion, M6, M18 and M30 (only at inclusion for group C).', 'armGroupLabels': ['Group A : Patients with acute major cardiovascular event', 'Group B: Patients with severe chronic cardiovascular disease', 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'Group D: Patients cured of HAP']}, {'name': 'Oropharyngeal swabs', 'type': 'OTHER', 'description': 'An oropharyngeal swab will be taken to analyze patients\\' upper airway microbiome at inclusion, M6, M18 and M30.', 'armGroupLabels': ['Group A : Patients with acute major cardiovascular event', 'Group B: Patients with severe chronic cardiovascular disease', 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'Group D: Patients cured of HAP']}, {'name': 'Calcium score (CT scan)', 'type': 'OTHER', 'description': 'A calcium score will be taken at 30 months, to assess individual cardiovascular risk.', 'armGroupLabels': ['Group A : Patients with acute major cardiovascular event', 'Group B: Patients with severe chronic cardiovascular disease', 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'Group D: Patients cured of HAP']}, {'name': 'ECG', 'type': 'OTHER', 'description': 'Performed at inclusion, M6, M18 and M30', 'armGroupLabels': ['Group A : Patients with acute major cardiovascular event', 'Group B: Patients with severe chronic cardiovascular disease', 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'Group D: Patients cured of HAP']}, {'name': 'Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test', 'type': 'OTHER', 'description': 'Cardiopulmonary exercise test, spirometry, plethysmography, pulmonary absorption of carbon monoxide in a single inspiration, and 6-minute walk test: These tests will be performed consecutively for 2 hours at inclusion (6-minute walk test only), at M6 and at M30. These tests will be performed to assess respiratory and cardiac function.', 'armGroupLabels': ['Group A : Patients with acute major cardiovascular event', 'Group B: Patients with severe chronic cardiovascular disease', 'Group C: Patients with a high risk of CVD, yet no known history of CVRD or HA', 'Group D: Patients cured of HAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sigismond LASOCKI', 'role': 'CONTACT', 'email': 'silasocki@chu-angers.fr', 'phone': '+33 2 41 35 36 35'}, {'name': 'Sigismond LASOCKI', 'role': 'CONTACT'}], 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine ROQUILLY', 'role': 'CONTACT', 'email': 'Antoine.roquilly@univ-nantes.fr', 'phone': '+33 2 40 58 22 30'}, {'name': 'Cécile POULAIN', 'role': 'CONTACT'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yoann LAUNEY', 'role': 'CONTACT', 'email': 'yoann.launey@chu-rennes.fr', 'phone': '+33 2 99 28 24 56'}, {'name': 'Yoann LAUNEY', 'role': 'CONTACT'}], 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel BESNIER', 'role': 'CONTACT', 'email': 'Emmanuel.Besnier@chu-rouen.fr', 'phone': '+33 2 32 88 89 90'}, {'name': 'Emmanuel BESNIER', 'role': 'CONTACT'}], 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fanny BOUNES', 'role': 'CONTACT', 'email': 'bounes.f@chu-toulouse.fr', 'phone': '+33 5 61 32 27 99'}, {'name': 'Fanny BOUNES', 'role': 'CONTACT'}], 'facility': 'Toulouse University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Antoine ROQUILLY', 'role': 'CONTACT', 'email': 'Antoine.roquilly@univ-nantes.fr', 'phone': '+33253482840'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}