Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-04-08 @ 5:15 AM
Study NCT ID:
NCT06717204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603960', 'term': 'vericiguat'}, {'id': 'D055553', 'term': 'Prescription Drugs'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2024-12-01', 'studyFirstSubmitQcDate': '2024-12-01', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LVEDVI=LVEDV/BSA', 'timeFrame': 'From baseline to the end of 12-month treatment', 'description': 'Changes of left ventricular end-diastolic volume index (LVEDVI) compared with baseline after 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFrEF', 'Myocardial Infarction', 'Vericiguat'], 'conditions': ['HFrEF - Heart Failure With Reduced Ejection Fraction', 'Myocardial Infarction (MI)']}, 'descriptionModule': {'briefSummary': 'The effects of vericiguat on cardiac remodeling in patients with chronic stable heart failure after myocardial infarction have not been reported. This project aims to clarify the efficacy and safety of vericiguat in patients with chronic heart failure after myocardial infarction. Patients with chronic stable heart failure with reduced ejection fraction after myocardial infarction in the electronic medical records of Qilu Hospital of Shandong University will be selected and divided into two groups: the treatment group received vericiguat in addition to conventional treatment and the control group received conventional treatment only. After 12-month treatment, the effects of vericiguat on cardiac remodeling and function and cardiovascular adverse events will be evaluated. The results are helpful to provide a new treatment strategy for chronic heart failure after myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic heart failure with reduced ejection fraction after myocardial infarction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The history of acute myocardial infarction exceeds 3 months;\n2. Symptoms and signs of heart failure have been stable for more than one month;\n3. 18 years old or more;\n4. NYHA cardiac function classified as grade II\\~IV;\n5. LVEF≤40%；\n6. NT-proBNP≥450pg/ml；\n7. All subjects or their guardians must sign the subject consent before entering the trial.\n\nExclusion Criteria:\n\n1. Patients with the following diseases: nonischemic cardiomyopathy; valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor;\n2. Mechanical complications of myocardial infarction;\n3. Unable to obtain primary outcome data.'}, 'identificationModule': {'nctId': 'NCT06717204', 'acronym': 'HFrEF', 'briefTitle': 'Vericiguat for Heart Failure With Reduced Ejection Fraction After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Vericiguat for Ventricular Remodeling in Patients With Heart Failure With Reduced Ejection Fraction After Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Vericiguat for HFrEF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vericiguat and conventional treatment', 'description': 'Vericiguat in addition to conventional treatment', 'interventionNames': ['Drug: Vericiguat Oral Tablet [Verquvo]', 'Drug: Prescription Drugs']}, {'label': 'Conventional treatment only', 'description': 'Conventional treatment only', 'interventionNames': ['Drug: Prescription Drugs']}], 'interventions': [{'name': 'Vericiguat Oral Tablet [Verquvo]', 'type': 'DRUG', 'otherNames': ['Conventional treatment'], 'description': 'Vericiguat in addition to conventional treatment', 'armGroupLabels': ['Vericiguat and conventional treatment']}, {'name': 'Prescription Drugs', 'type': 'DRUG', 'otherNames': ['Conventional treatment without vericiguat'], 'description': 'Conventional treatment only', 'armGroupLabels': ['Conventional treatment only', 'Vericiguat and conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Panpan Hao, MD, PhD', 'role': 'CONTACT', 'email': 'panda.how@sdu.edu.cn', 'phone': '86-18560086593'}, {'name': 'Panpan Hao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Bin Li, MD, PhD', 'role': 'CONTACT', 'email': 'qingquan0615@163.com', 'phone': '86-0531-85695114'}, {'name': 'Bin Li, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250031', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Zhongwen Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhongwen@sdu.edu.cn', 'phone': '86-0531-89268763'}, {'name': 'Zhongwen Zhang, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Shandong First Medical University/Shandong Province Qianfoshan Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Panpan Hao, MD, PhD', 'role': 'CONTACT', 'email': 'panda.how@sdu.edu.cn', 'phone': '86-18560086593'}], 'overallOfficials': [{'name': 'Panpan Hao, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Institutional policy and patient privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinan Central Hospital', 'class': 'OTHER'}, {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pan-Pan Hao', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}