Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 7:36 PM
Study NCT ID:
NCT06825728
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-13
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metoprolol in Patients With HFrEF and COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 311}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoints (all-cause death and rehospitalization)', 'timeFrame': 'From enrollment to the end of treatment at 24 months.', 'description': 'Rehospitalization included readmission for heart failure and/or COPD.'}], 'secondaryOutcomes': [{'measure': 'All-cause death', 'timeFrame': 'From enrollment to the end of treatment at 24 months.'}, {'measure': 'Cardiovascular death', 'timeFrame': 'From enrollment to the end of treatment at 24 months.'}, {'measure': 'Rehospitalization for heart failure', 'timeFrame': 'From enrollment to the end of treatment at 24 months.'}, {'measure': 'Re-hospitalization for COPD', 'timeFrame': 'From enrollment to the end of treatment at 24 months.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure with Reduced Ejection Fraction', 'Chronic Obstructive Pulmonary Disease', 'Metoprolol'], 'conditions': ['Heart Failure With Reduced Ejection Fraction (HFrEF)', 'COPD (Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': 'The goal of the clinical trial was to see if Metoprolol was effective in treating patients with heart failure and chronic obstructive pulmonary disease. It will also learn about the safety of Metoprolol. The main questions it aims to answer are:\n\nDid Metoprolol reduce the frequency of all-cause deaths and re-hospitalizations in subjects? What medical problems do participants experience after taking Metoprolol? The researchers will compare different doses of Metoprolol to see the best dose for Metoprolol.\n\nParticipants will:\n\nTake Metoprolol 23.75mg/ day or the maximum tolerable dose of Metoprolol daily for 24 months.\n\nRegular outpatient follow-up visits to the research center. Their symptoms and Metoprolol dosage were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;\n2. A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC \\< 0.7 and FEV1 \\< 80% of the expected value);\n3. Age ≥18 years old;\n4. Informed consent has been obtained and signed.\n\nExclusion Criteria:\n\n1. the dose of Metoprolol before enrollment was more than 23.75mg/d;\n2. Resting heart rate \\< 50 beats/min;\n3. Second or third degree atrioventricular block;\n4. Atrial fibrillation;\n5. Sick sinus syndrome;\n6. Systolic blood pressure \\< 90mmHg;\n7. Acute attack of bronchial asthma;\n8. Liver insufficiency (serum transaminase \\> 3 times the normal value);\n9. Renal insufficiency (eGFR \\< 30ml/min/1.73m2, or serum creatinine \\> 2.5mg/dL\\[\\> 221μmol/L\\]);\n10. Patients with serious physical diseases, such as cancer;\n11. Patients who have a history of allergy to the investigational drug or its ingredients;\n12. Participating in other clinical investigators;\n13. During the study period, Patients cannot live in the selected center for a long time, which is not conducive to the follow-up;\n14. Patients with disability, mobility disability, intellectual disability and other factors that may prevent normal participation in the study and follow-up, and their frailty was assessed by the FRAIL frailty screening scale; Intellectual mental status was assessed by the Mini-Mental State Examination (MMSE).\n15. Poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.'}, 'identificationModule': {'nctId': 'NCT06825728', 'briefTitle': 'Metoprolol in Patients With HFrEF and COPD', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Metoprolol in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '202412231'}, 'secondaryIdInfos': [{'id': '2022YFC2010004', 'type': 'OTHER_GRANT', 'domain': 'National key research and development plan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The experimental group received the maximum tolerable dose of Metoprolol.', 'interventionNames': ['Drug: Different doses of Metoprolol.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The control group received 23.75mg/d of Metoprolol.', 'interventionNames': ['Drug: Different doses of Metoprolol.']}], 'interventions': [{'name': 'Different doses of Metoprolol.', 'type': 'DRUG', 'description': 'The control group received 23.75mg/d of metoprolol, and the experimental group received the maximum tolerable dose of metoprolol.', 'armGroupLabels': ['Control Group', 'Experimental Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}