Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-29 @ 10:52 PM
Study NCT ID:
NCT06844032
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Poor Prognosis in HFpEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2025-02-19', 'studyFirstSubmitQcDate': '2025-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization for exacerbation of HF', 'timeFrame': 'From enrollment to August 2025'}, {'measure': 'All-cause mortality', 'timeFrame': 'From enrollment to August 2025'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFpEF', 'HF', 'diastolic dysfunction', 'left ventricle (LV) filling pressures', 'left ventricular hypertrophy', 'cardiac reserves', 'myocardial fibrosis'], 'conditions': ['HFpEF']}, 'descriptionModule': {'briefSummary': 'Patients with HFpEF who have undergone meticulous clinical and instrumental evaluation (including diastolic exercise testing) between 2013 and 2020, will be followed up for at least 3 years.', 'detailedDescription': 'Heart failure with preserved ejection fraction (HFpEF) is a serious condition with an unfavorable prognosis.\n\nThe investigators aimed to evaluate in patients with HFpEF:\n\n* the prognostic significance of standard resting hemodynamic parameters compared to key cardiac reserves;\n* the prognostic significance of clinical parameters (sex, age, NYHA class, extra-cardiac diseases, therapy);\n* the prognostic significance of biological markers of hemodynamic stress and biomarkers of inflammation and fibrosis;\n* to identify independent predictors of adverse prognosis of HFpEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with HFpEF who underwent meticulous clinical evaluation between 2013 and 2020 at the National Medical Research Centre for Cardiology (Moscow, Russian Federation)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed and data informed consent;\n2. New York Heart Association (NYHA) class II-III heart failure;\n3. Left ventricular ejection fraction \\> 50%;\n4. Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.\n\nExclusion Criteria:\n\n1. Evidence of myocardial ischemia during stress echocardiography;\n2. Significant lesions of the main coronary arteries;\n3. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);\n4. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;\n5. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);\n6. Primary pulmonary artery hypertension;\n7. Significant left-sided structural valve disease;\n8. Anemia (Hb \\< 100 g/L);\n9. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2 (CKD-EPI);\n10. Non-cardiac conditions that complicate/exclude participation in the study;\n11. Exacerbation of heart failure less than 3 months prior to study entry.'}, 'identificationModule': {'nctId': 'NCT06844032', 'briefTitle': 'Predictors of Poor Prognosis in HFpEF', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation'}, 'officialTitle': 'Clinical, Hemodynamic and Neurohumoral Predictors of Poor Prognosis in Heart Failure with Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'AAAA-A18-118022290061-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with primary outcome', 'description': 'Patients with HFpEF who experienced primary outcome (were hospitalized for HF or died)'}, {'label': 'without primary outcome', 'description': 'Patients with HFpEF who survived without hospitalization for HF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '121552', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Artem Ovchinnikov, MD, PhD, DSc', 'role': 'CONTACT', 'email': 'artcardio@mail.ru'}], 'facility': 'Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Artem G Ovchinnikov, MD, PhD, DSc', 'role': 'CONTACT', 'email': 'artcardio@mail.ru', 'phone': '+74954146612'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, MD', 'investigatorFullName': 'Anastasiia Filatova, MD, PhD', 'investigatorAffiliation': 'National Medical Research Center for Cardiology, Ministry of Health of Russian Federation'}}}}