Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension

NCT ID: NCT05638503

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type OTHER

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

Intervention Type OTHER

Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Left ventricular hypertrophy

Hypertension with normal left ventricular geometry and left ventricular concentric remodeling

Intervention Type OTHER

Left ventricular non-hypertrophy

Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 30-75 years old;
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

1. Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;
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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mei Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mei Zhang, PhD

Role: CONTACT

+86-18560086629

Yu Zhang, PhD

Role: CONTACT

+86-18560088296

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lijuan Bu, PhD

Role: primary

+86-18560088816

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QLCR20220272

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.