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

NCT05638503 | Recruiting DMC

• 1 other identifier: QLCR20220272
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; Echocardiography; Cardiovascular remodeling

Outcome Measures

Primary Outcomes (3)

• Emerging atrial fibrillation

  The differences in the incidence of atrial fibrillation between the two groups

  Through study completion, on average once a year.

• Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death

  The differences in the incidence of unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death between the two groups

  Through study completion, on average once a year.

• Emerging transient ischemic attack (TIA) or stroke

  The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups

  Through study completion, on average once a year.

Secondary Outcomes (5)

• Emerging decreased cardiac function with preserved ejection fraction

  Through study completion, on average once a year.

• Emerging cardiac remodeling

  Through study completion, on average once a year.

• Emerging aortic aneurysm or aortic dissection

  Through study completion, on average once a year.

• Emerging serious arrhythmias

  Through study completion, on average once a year.

• The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes

  Through study completion, on average once a year.

Study Arms (2)

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

Other: Left ventricular hypertrophy

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

Other: Left ventricular non-hypertrophy

Interventions

Left ventricular hypertrophy OTHER

Hypertension with normal left ventricular geometry and left ventricular concentric remodeling

Hypertension with left ventricular hypertrophy group

Left ventricular non-hypertrophy OTHER

Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Hypertension with left ventricular non-hypertrophy group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 30-75 years old;
• 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;
• Left ventricular ejection fraction was normal (LVEF ≥ 0.5).
• All patients agreed to participate in the experiment and signed the informed consent form.

You may not qualify if:

• Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;
• Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;
• Abnormal liver function; abnormal renal function and diabetes;
• Pregnant or breastfeeding women;
• Expected survival time due to non-cardiovascular disease\<4 years;
• Patients with poor echocardiographic image quality.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mei Zhang, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Zhang, PhD

CONTACT

+86-18560086629; daixh@vip.sina.com

Yu Zhang, PhD

CONTACT

+86-18560088296; zhangyu_505@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 6, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

CN (1)