Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-27 @ 8:13 PM
Study NCT ID:
NCT05638503
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2022-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-14', 'size': 334812, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-14T22:53', 'hasProtocol': True}, {'date': '2022-08-14', 'size': 127676, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-11-14T22:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2022-11-15', 'studyFirstSubmitQcDate': '2022-11-27', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emerging atrial fibrillation', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences in the incidence of atrial fibrillation between the two groups'}, {'measure': 'Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences in the incidence of unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death between the two groups'}, {'measure': 'Emerging transient ischemic attack (TIA) or stroke', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups'}], 'secondaryOutcomes': [{'measure': 'Emerging decreased cardiac function with preserved ejection fraction', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences between the two groups in the incidence of decreased cardiac function with preserved ejection fraction measured by echocardiography compared to that at the baseline'}, {'measure': 'Emerging cardiac remodeling', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences between the two groups in the incidence of cardiac remodeling measured by echocardiography compared to that at the baseline'}, {'measure': 'Emerging aortic aneurysm or aortic dissection', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences in the incidence of aortic aneurysm or aortic dissection between the two groups'}, {'measure': 'Emerging serious arrhythmias', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'ECG showed that QTc (QT interval corrected by heart rate) was more than 500ms or QTc was longer than the baseline level for more than 60ms, emerging torsade de pointes ventricular tachycardia and other serious arrhythmias'}, {'measure': 'The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes', 'timeFrame': 'Through study completion, on average once a year.', 'description': 'The differences between the two groups in the incidence of the deviations between blood pressure and cardiac function parameters at the same day measured by echocardiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Echocardiography', 'Cardiovascular remodeling'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Then the investigators want to enroll twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up. Echocardiographic measurement parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.', 'detailedDescription': 'Different configurations of hypertension are important risk factor for the morbidity and mortality of cardiovascular and cerebrovascular diseases in China. Studies have shown that left ventricular hypertrophy (LVH) and left atrial enlargement caused by hypertension are independent risk factors for cardiovascular events. The LVM and LAV derived from the normal value data of Chinese healthy adults have been reported to be different from the recommended reference values in guidelines, and the distribution characteristics of hypertension remodeling are also different. However, the characteristics and outcomes of cardiac remodeling in Chinese hypertensive population and whether this difference in configuration has an impact on the treatment, prognosis and cardiovascular events of hypertensive population are still needed to be explored.\n\nThis study was to observe the relationship between blood pressure and cardiovascular remodeling evaluated by different standards in hypertensive population, and compare the relationship between different cardiac configurations and cardiovascular events in Chinese hypertensive population.\n\nTwenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up.\n\nEchocardiographic measurement parameters including M-mode and two-dimensional ultrasonic parameters; doppler ultrasound parameters; relevant parameters of two-dimensional speckle tracking, myocardial work parameters; the left ventricular remodeling parameters (LVM and RWT); cardiac morphological changes; three-dimensional ultrasound parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 30-75 years old;\n2. No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg;\n3. Left ventricular ejection fraction was normal (LVEF ≥ 0.5).\n4. All patients agreed to participate in the experiment and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;\n2. Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;\n3. Abnormal liver function; abnormal renal function and diabetes;\n4. Pregnant or breastfeeding women;\n5. Expected survival time due to non-cardiovascular disease\\<4 years;\n6. Patients with poor echocardiographic image quality.'}, 'identificationModule': {'nctId': 'NCT05638503', 'briefTitle': 'Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension', 'orgStudyIdInfo': {'id': 'QLCR20220272'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertension with left ventricular hypertrophy group', 'description': '2015 ASE/EACVI guideline standard: Eccentric hypertrophy, EH: LVMI\\>115g/ m2（male）or LVMI\\>95g/ m2（female）and RWT≤0.42 Concentric hypertrophy, CH: LVMI\\>115g/ m2（male）or LVMI\\>95g/ m2（female）and RWT\\>0.42\n\nReference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:\n\nEccentric hypertrophy, EH: LVMI\\>108g/ m2（male）and RWT≤0.51or LVMI\\>99g/ m2（female）and RWT≤0.49 Concentric hypertrophy, CH: LVMI\\>108g/ m2（male）and RWT\\>0.51 or LVMI\\>99g/ m2（female）and RWT\\>0.49', 'interventionNames': ['Other: Left ventricular hypertrophy']}, {'label': 'Hypertension with left ventricular non-hypertrophy group', 'description': '2015 ASE/EACVI guideline standard: Normal left ventricular geometry, NG: LVMI≤115g/m2（male）or LVMI≤95g/m2（female）and RWT≤0.42 Concentric remodeling, CR: LVMI≤115g/m2（male）or LVMI≤95g/ m2（female）and RWT\\>0.42\n\nReference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:\n\nNormal left ventricular geometry, NG: LVMI≤108g/ m2（male）and RWT≤0.51 or LVMI≤99g/ m2（female）and RWT\\>0.49 Concentric remodeling, CR: LVMI≤108g/ m2（male）and RWT\\>0.51 or LVMI≤99g/ m2（female）and RWT\\>0.49', 'interventionNames': ['Other: Left ventricular non-hypertrophy']}], 'interventions': [{'name': 'Left ventricular hypertrophy', 'type': 'OTHER', 'description': 'Hypertension with normal left ventricular geometry and left ventricular concentric remodeling', 'armGroupLabels': ['Hypertension with left ventricular hypertrophy group']}, {'name': 'Left ventricular non-hypertrophy', 'type': 'OTHER', 'description': 'Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy', 'armGroupLabels': ['Hypertension with left ventricular non-hypertrophy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijuan Bu, PhD', 'role': 'CONTACT', 'email': 'qlyykyc@163.ocm', 'phone': '+86-18560088816'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Mei Zhang, PhD', 'role': 'CONTACT', 'email': 'daixh@vip.sina.com', 'phone': '+86-18560086629'}, {'name': 'Yu Zhang, PhD', 'role': 'CONTACT', 'email': 'zhangyu_505@126.com', 'phone': '+86-18560088296'}], 'overallOfficials': [{'name': 'Mei Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}