Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT05792059
Status:
UNKNOWN
Last Update Posted:
2023-04-06
First Post:
2023-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-03-17', 'studyFirstSubmitQcDate': '2023-03-17', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "An increased of post-exercise E/e' ratio", 'timeFrame': 'during diastolic stress test (baseline)'}, {'measure': 'An increased of post-exercise pulmonary artery systolic pressure (PASP)', 'timeFrame': 'during diastolic stress test (baseline)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction (HFpEF)']}, 'descriptionModule': {'briefSummary': 'Prevalence of heart failure with preserved ejection fraction (HFpEF) continues to increase in the developed world, likely because of the increasing life expectancy and an increasing number of elderly patients.\n\nTransthoracic echocardiography is essential for the diagnosis of HFpEF according to the current guidelines. The HFA-PEFF and H2FPEF diagnostic algorithms rely on clinical characteristics and echocardiography findings that indicate the presence of diastolic dysfunction.\n\nThese diagnostic algorithms are not applicable in remote areas where expert echocardiography cannot be performed due to the absence of modern ultrasound systems and lack of qualified specialists. Therefore, it is important to develop an algorithm to evaluate pre-test probability of HFpEF without echocardiographic markers, so it can be easily used in the primary outpatient care setting by any specialist.\n\nThe aim of this study is to find the associations between clinical and epidemiological characteristics and changes of intracardiac hemodynamics in patients with dyspnea and decreased exercise tolerance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients complaining of shortness of breath, with two or more chronic non-communicable diseases (patients with comorbidities)\n\nExclusion Criteria:\n\n* Morbid obesity;\n* Any chronic diseases in the stage of exacerbation and / or decompensation;\n* Systemic diseases, cancer;\n* Cardiac arrhythmias: persistent atrial fibrillation or paroxysmal atrial fibrillation with frequent paroxysms;\n* History of myocardial infarction, stroke, heart failure with reduced ejection fraction;\n* Storage diseases, hypertrophic cardiomyopathy, concentric hypertrophy;\n* Congenital and acquired heart defect;'}, 'identificationModule': {'nctId': 'NCT05792059', 'acronym': 'EMPATHY-HF', 'briefTitle': 'DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center for Therapy and Preventive Medicine'}, 'officialTitle': 'DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction (EMPATHY-HF)', 'orgStudyIdInfo': {'id': '01-02/23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with HFpEF'}, {'label': 'patients without HFpEF'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Olga Dzhioeva', 'role': 'CONTACT', 'email': 'odzhioeva@gnicpm.ru', 'phone': '+79166141821'}], 'facility': 'National Medical Research Center for Therapy and Preventive Medicine', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Olga Dzhioeva', 'role': 'CONTACT', 'email': 'odzhioeva@gnicpm.ru', 'phone': '+7 (916) 614-18-21'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center for Therapy and Preventive Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}