Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:35 PM
Study NCT ID:
NCT07375433
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D013147', 'term': 'Spirometry'}, {'id': 'D010993', 'term': 'Plethysmography, Whole Body'}, {'id': 'D000070857', 'term': 'Walk Test'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'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': 'D010991', 'term': 'Plethysmography'}, {'id': 'D005080', 'term': 'Exercise Test'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary composite endpoin', 'timeFrame': '1 year', 'description': 'Primary composite endpoint: all-cause death, rehospitalizations, major adverse cardiovascular events (MACE)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Heart failure with Preserved Ejection Fraction', 'Biomarkers', 'COPD', 'Prognosis'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)', 'Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)']}, 'descriptionModule': {'briefSummary': 'Study aim is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.', 'detailedDescription': 'Study aim of Investigation "Heart Failure with Preserved Ejection Fraction in Patients with Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis" (HIPSTER) is comparison of heart failire with preserved ejection fraction (HFpEF) detection rate in patients with Сhronic Obstructive Pulmonary Disease (COPD) and the clinical course and prognosis in patients with COPD depending on HFpEF presence.\n\nIt is assumed that newly diagnosed HFpEF will occur in at least 6% (COPD PRIORITY data) of cases, and, the presence of HFpEF will negatively affect both the manifestations of the disease and the outcomes and prognosis\n\nDuring the study it is planned to:\n\n1. Perform a retrospective analysis of patient records, determine the frequency of intracardiac hemodynamic disorders, corresponding with the criteria for HFpEF and compare them with the diagnosis in clinical records.\n2. Identify the patients with previously undiagnosed HFpEF among patients with COPD, and evaluate the frequency of cardiorespiratory comorbidity.\n3. Examine the general clinical and biochemical blood test parameters in the study groups (as part of a routine in-patient examination).\n4. Evaluate echocardiography parameters in the study groups (as part of a routine protocol + epicardial adipose tissue thickness (EAT), E/e\', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension (EDD).\n5. Compare spirometry and body plethysmography parameters in the groups depending on the presence of HFpEF criteria.\n6. Compare the functional status (Six-Minute Walk Test, 6MWT) in the study groups.\n7. Evaluate patient\'s vital status after 12 months, information about hospitalizations and their reasons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Generic russian population', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Verified diagnosis of COPD;\n2. Patients hospitalized with COPD;\n3. Citizenship of the Russian Federation;\n4. Patients aged 50 to 70 years;\n5. Patient consent to participate in the study.\n\nExclusion Criteria:\n\n1. Lack of Russian Federaion citizenship;\n2. Patient's refusal to participate in the study;\n3. Any chronic diseases, other than COPD, that affect the prognosis, in the acute and/or decompensated stage;\n4. Mental disorders."}, 'identificationModule': {'nctId': 'NCT07375433', 'acronym': 'HIPSTER', 'briefTitle': 'Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Therapy and Preventive Medicine'}, 'officialTitle': 'Heart Failure With Preserved Ejection Fraction in Patients With Сhronic Obstructive Pulmonary Disease: Clinical Course and Prognosis', 'orgStudyIdInfo': {'id': '06-08/25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Сhronic Obstructive Pulmonary Disease', 'description': 'Patients hospitalized with a verified diagnosis of COPD. Patients with a confirmed diagnosis in accordance with instrumental and clinical criteria.', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: Spirometry', 'Diagnostic Test: Body plethysmography', 'Diagnostic Test: 6-Minute Walk Test (6MWT)', 'Diagnostic Test: laboratory biomarker analysis']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': "Transthoracic echocardiography at rest: with determination of epicardial fat tissue thickness, epicardial adipose tissue thickness (EAT), E/e', interventricular septum thickness, left ventricular posterior wall thickness, and end-diastolic dimension", 'armGroupLabels': ['Patients with Сhronic Obstructive Pulmonary Disease']}, {'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spirometry is the most common of the pulmonary function tests, which measures the lung capacity and airway patency (volume and speed of air) during quiet and forced breathing.', 'armGroupLabels': ['Patients with Сhronic Obstructive Pulmonary Disease']}, {'name': 'Body plethysmography', 'type': 'DIAGNOSTIC_TEST', 'description': "Body plethysmography is a non-invasive lung function test performed in a sealed booth (body box) that measures total lung volume, functional residual capacity, and airway resistance by using Boyle's Law to track pressure and volume changes as a patient breathes, providing crucial data for diagnosing conditions like COPD and asthma, and differentiating them from other lung disorders", 'armGroupLabels': ['Patients with Сhronic Obstructive Pulmonary Disease']}, {'name': '6-Minute Walk Test (6MWT)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity', 'armGroupLabels': ['Patients with Сhronic Obstructive Pulmonary Disease']}, {'name': 'laboratory biomarker analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine and special laboratory tests', 'armGroupLabels': ['Patients with Сhronic Obstructive Pulmonary Disease']}]}, 'contactsLocationsModule': {'locations': [{'city': "Kazan'", 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Diana I Abdulganieva, MD, professor', 'role': 'CONTACT', 'email': 'diana.abdulganieva@kazangmu.ru', 'phone': '+78432360922'}, {'name': 'Elina R Kirillova, PhD, Associate Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nailya G Shamsutdinova, PhD, Associate Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Diana I Abdulganieva, MD, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kazan State Medical University', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Olga N. Dzhioeva, MD, Associate Professor', 'role': 'CONTACT', 'email': 'odzhioeva@gnicpm.ru', 'phone': '+79166141821'}, {'name': 'Yriy S Timofeev, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizaveta A. Rogozhkina, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olga N Dzhioeva, PhD, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Medical Research Center for Therapy and Preventive Medicine', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Yury S Timofeev, PhD', 'role': 'CONTACT', 'email': 'Timofeev_lab@mail.ru', 'phone': '+79150104788'}], 'overallOfficials': [{'name': 'Olga D Dzhioeva, MD, associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Medical Research Center for Therapy and Preventive Medicine'}, {'name': 'Diana I Abdulganieva, MD, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kazan State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Therapy and Preventive Medicine', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Kazan State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}