Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
NCT ID: NCT05638503
Last Updated: 2024-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2200 participants
OBSERVATIONAL
2022-05-01
2027-12-31
Brief Summary
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Detailed Description
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This 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.
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 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hypertension with left ventricular hypertrophy group
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
Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:
Eccentric 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
Left ventricular hypertrophy
Hypertension with normal left ventricular geometry and left ventricular concentric remodeling
Hypertension with left ventricular non-hypertrophy group
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
Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:
Normal 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
Left ventricular non-hypertrophy
Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy
Interventions
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Left ventricular hypertrophy
Hypertension with normal left ventricular geometry and left ventricular concentric remodeling
Left ventricular non-hypertrophy
Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. Left ventricular ejection fraction was normal (LVEF ≥ 0.5).
4. All patients agreed to participate in the experiment and signed the informed consent form.
Exclusion Criteria
2. Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;
3. Abnormal liver function; abnormal renal function and diabetes;
4. Pregnant or breastfeeding women;
5. Expected survival time due to non-cardiovascular disease\<4 years;
6. Patients with poor echocardiographic image quality.
30 Years
75 Years
ALL
Yes
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Principal Investigators
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Mei Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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QLCR20220272
Identifier Type: -
Identifier Source: org_study_id
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