Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-06 @ 1:19 AM
Study NCT ID:
NCT03197350
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2017-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will compare 3 different groups: controls and HFpEF patients and HFrEF patients, in order to better understand the pathophysiology in HF with preserved ejection fraction.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-01', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognosis with a follow up including HF hospitalizations and/or deaths.', 'timeFrame': '6 months', 'description': 'A follow up will be done by the investigators. After that, they will determine if fibrosis estimated by cMR or biomarkers is a significant prognostic factor.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure with preserved ejection fraction', 'Imaging', 'Prognosis'], 'conditions': ['Heart Failure, Preserved Ejection Fraction', 'Cardiac Fibrosis', 'Biomarkers', 'Magnetic Resonance Imaging']}, 'referencesModule': {'references': [{'pmid': '40121452', 'type': 'DERIVED', 'citation': 'Menghoum N, Badii MC, Leroy M, Parra M, Roy C, Lejeune S, Vancraeynest D, Pasquet A, Brito D, Casadei B, Depoix C, Filippatos G, Gruson D, Edelmann F, Ferreira VM, Lhommel R, Mahmod M, Neubauer S, Persu A, Piechnik S, Hellenkamp K, Ikonomidis I, Krakowiak B, Pieske B, Pieske-Kraigher E, Pinto F, Ponikowski P, Senni M, Trochu JN, Van Overstraeten N, Wachter R, Gerber BL, Balligand JL, Beauloye C, Pouleur AC. Exploring the impact of metabolic comorbidities on epicardial adipose tissue in heart failure with preserved ejection fraction. Cardiovasc Diabetol. 2025 Mar 22;24(1):134. doi: 10.1186/s12933-025-02688-7.'}, {'pmid': '39077419', 'type': 'DERIVED', 'citation': 'Lejeune S, Ginion A, Menghoum N, Vancraeynest D, Pasquet A, Gerber BL, Horman S, Beauloye C, Pouleur AC. Association of Plasma Myeloperoxidase with Inflammation and Diabetic status in HFpEF. Rev Cardiovasc Med. 2023 Feb 8;24(2):56. doi: 10.31083/j.rcm2402056. eCollection 2023 Feb.'}, {'pmid': '30086783', 'type': 'DERIVED', 'citation': 'Roy C, Slimani A, de Meester C, Amzulescu M, Pasquet A, Vancraeynest D, Beauloye C, Vanoverschelde JL, Gerber BL, Pouleur AC. Associations and prognostic significance of diffuse myocardial fibrosis by cardiovascular magnetic resonance in heart failure with preserved ejection fraction. J Cardiovasc Magn Reson. 2018 Aug 8;20(1):55. doi: 10.1186/s12968-018-0477-4.'}]}, 'descriptionModule': {'briefSummary': 'The goals of this research will be to define some of the mechanisms underlying the progression and complications of heart failure (HF) with preserved left ventricular ejection fraction (HFPEF)\n\nAim 1: to evaluate the differences in cardiac structure, function and fibrosis markers through the spectrum of HF stages in order to deepen the understanding of the pathophysiology driving HF progression.\n\nAim 2: to define the mechanisms by which HF risk factors, such as hypertension, diabetes, obesity, and renal insufficiency, interact with age to increase HF risk, and to evaluate the role of precipitating factors such as myocardial ischemia, atrial fibrillation in HFPEF.\n\nAim 3: to determine prognostic factors in HFPEF patients, by following these patients over time. Accordingly the investigators will correlate baseline data (echocardiographic, MRI or biomarkers) with incident cardiovascular events and determine whether these measures provide incremental prognostic information beyond clinical characteristics.', 'detailedDescription': 'Heart failure (HF) is a prevalent and complex clinical syndrome characterized by significant morbidity and mortality. HF patients are classified into two major groups based on their left ventricular ejection fraction (LVEF): heart failure with reduced ejection fraction (HFrEF) (LVEF \\< 40%) and heart failure with preserved ejection fraction (HFpEF) (LVEF ≥ 50%). These groups exhibit distinct clinical and biological characteristics, and their underlying pathophysiology have been thoroughly investigated. However, HFpEF, which represents more than 50% of HF cases, remains a poorly understood disease with limited therapeutic options\n\nSeveral proposed mechanisms contribute to the development of HFpEF, including systemic inflammation, microvascular dysfunction, cardiometabolic abnormalities, and interstitial fibrosis. The aim of our research programm is to understand the differences between the pathophysiology of this syndrome compared to that of heart failure with reduced EF, with a focus on cardiac fibrosis and metabolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Controls without an history of HF and previous cardiovascular disease will be recruited\n\nInclusion Criteria for HF patients:\n\nPatients need to have typical symptoms and signs of HF, New York Heart Association (NYHA) functional class II or higher, N-terminal pro-B type natriuretic peptide (NT-proBNP) \\>350pg/mL, or an hospitalization for HF within the previous 12 months. Left ventricular ejection fraction (LVEF) is required to be lower than 40% in patients with HFrEF and 50% or higher in HFpEF, with evident signs of diastolic dysfunction ( LA \\> 34 ml/m²; E/e' \\> 14; TR \\>2.8 ms, septal e' velocity \\< 7 cm/s or Lateral e' velocity \\<10 cm/s)\n\nExclusion Criteria for HF patients:\n\nPatients with severe valvular disease, infiltrative or hypertrophic cardiomyopathy, acute coronary syndrome in the previous 30 days, chronic obstructive pulmonary disease GOLD 3 or 4, congenital heart disease, pericardial disease, terminal renal failure (eGFR \\< 15mL/min/1,73m²) or subjects requiring dialysis, atrial fibrillation with a ventricular response \\> 140 bpm, severe anemia (hemoglobin \\< 8 g/dL), liver dysfunction, and evolving cancer will be excluded"}, 'identificationModule': {'nctId': 'NCT03197350', 'briefTitle': 'Characterization of Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Characterization of Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'HFpEF'}, 'secondaryIdInfos': [{'id': '2012/23AVR/199', 'type': 'OTHER', 'domain': 'CEHF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HFpEF', 'description': 'We intend to recruit consecutive patients admitted for HFPEF in our institution during the next years. Eligible patients include those with age ≥50 years, LVEF ≥50%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥350 pg/mL) within the 60 days before inclusion.\n\nIntervention: cMR', 'interventionNames': ['Diagnostic Test: cMR', 'Biological: biomarker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Controls', 'description': 'We plan to recruit 10 per decade of age. These subjects will allow us to evaluate the effects of age on the parameters of our study. They will have no risk factors, a normal ECG at rest and normal heart ultrasound and no abnormalities on a stress test.\n\nIntervention: cMR', 'interventionNames': ['Diagnostic Test: cMR', 'Biological: biomarker']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HFrEF', 'description': 'We intend to recruit consecutive patients admitted for HFrEF in our institution during the next years. Eligible patients include those with age ≥50 years, LVEF ≤40%, symptomatic HF, and either a hospitalization for HF within the prior year or an elevated natriuretic peptide level (BNP ≥100 pg/mL or NT-proBNP ≥350 pg/mL) within the 60 days before inclusion.\n\nIntervention: cMR', 'interventionNames': ['Diagnostic Test: cMR', 'Biological: biomarker']}], 'interventions': [{'name': 'cMR', 'type': 'DIAGNOSTIC_TEST', 'description': 'cardiac MRI done to complete the diagnosis', 'armGroupLabels': ['Controls', 'HFpEF', 'HFrEF']}, {'name': 'biomarker', 'type': 'BIOLOGICAL', 'description': 'Biomarker correlation with cMR parameters Prognostic information', 'armGroupLabels': ['Controls', 'HFpEF', 'HFrEF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Clotilde Roy', 'role': 'CONTACT'}], 'facility': 'Cliniques universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Anne-Catherine Pouleur', 'role': 'CONTACT', 'email': 'anne-catherine.pouleur@uclouvain.be', 'phone': '003227646600'}, {'name': 'Anne Catherine Pouleur', 'role': 'CONTACT', 'email': 'anne-catherine.pouleur@uclouvain.be', 'phone': '0032276600'}], 'overallOfficials': [{'name': 'Anne Catherine Pouleur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}