Effect of Aterial Stiffness on Myocardial Work in Patients With Hypertension

September 28, 2020 updated by: Dongying Zhang, Chongqing Medical University

Relationship Between Arteriosclerosis and Myocardial Work in Hypertensive Patients With Left Ventricular Ejection Fraction Retention

Hypertension is a serious threat to human health and a major global economic burden.Chronic hypertension can cause left ventricular remodeling and loss of function, eventually leading to heart failure.Exploring the early changes and mechanisms of left ventricular cardiac function caused by hypertension, and to identify individuals who may develop into serious heart injury, may play a positive role in the early prevention and control of heart failure caused by hypertension.Therefore, this study intend to use two-dimensional speckle tracking technology, a non-invasive method to measure left ventricular pressure-strain loop to quantitatively reflect cardiac work index , to study different hypertension patients with normal left ventricular ejection fraction the change of the global and local cardiac work, and the influence of aterosclerosis in thes patients to myocardial work, and explore their relationship with ventricular remodeling and abnormal diastolic function.To improve the understanding of the pathophysiology of hypertension, hypertensive heart disease and heart failure, and to provide scientific support for the early prevention and control of such diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypertension is a serious threat to human health and a major global economic burden.Chronic hypertension can cause left ventricular remodeling and loss of function, eventually leading to heart failure. Ventricular remodeling in hypertensive patients is an adaptive and decompensating response to persistent elevated blood pressure and increased myocardial work load. Exploring the early changes and mechanisms of left ventricular cardiac function caused by hypertension, and to identify individuals who may develop into serious heart injury, may play a positive role in the early prevention and control of heart failure caused by hypertension.Therefore, this study intend to use two-dimensional speckle tracking technology, a non-invasive method to measure left ventricular pressure-strain loop to quantitatively reflect cardiac work index , to study different hypertension patients with normal left ventricular ejection fraction (including hypertension without heart damage performance with different degree of high blood pressure, hypertension with diastolic dysfunction , hypertension with left ventricular hypertrophy ) the change of the global and local cardiac work, and the influence of aterosclerosis in thes patients to myocardial work, and explore their relationship with ventricular remodeling and abnormal diastolic function.To improve the understanding of the pathophysiology of hypertension, hypertensive heart disease and heart failure, and to provide scientific support for the early prevention and control of such diseases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: QIAN DUAN
  • Phone Number: 8613608393056

Study Locations

  • China
      • Chongqing, China, 400000
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hypertension patients evaluated by echocardiography in theEchocardiography Center of the First Affiliated Hospital of Chongqing Medical University from September 2020 to January 2021.

Description

Inclusion Criteria:

Age 18-65 years

The diagnostic criteria of hypertension were blood pressure systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg in the clinic or receiving antihypertensive drug treatment

The normal high-value diagnostic criteria for hypertension were systolic blood pressure 130-139mmhg and or diastolic blood pressure 85-90mmhg in the clinic

LVEF > 50%

Exclusion Criteria:

coronary atherosclerotic heart disease or symptoms of angina

Cardiomyopathy

Valvular heart disease

Diabetes

Atrial fibrillation

Renal function damage

Pregnancy

Secondary hypertension

Chemotherapy for malignant tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
normotensive group
The medical history and basic examination and examination information were collected. Echocardiography including conventional cardiac ultrasound, tissue Doppler and two-dimensional speckle tracking to measure myocardial strain and noninvasive myocardial work were carried out , and the brachial-ankle pulse wave velocity was measured in parallel.
Other: Echocardiography and pulse wave velocity measurement
Echocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement
Prehypertension group
The medical history and basic examination and examination information were collected. Echocardiography including conventional cardiac ultrasound, tissue Doppler and two-dimensional speckle tracking to measure myocardial strain and noninvasive myocardial work were carried out , and the brachial-ankle pulse wave velocity was measured in parallel.
Other: Echocardiography and pulse wave velocity measurement
Echocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement
hypertensive group
The medical history and basic examination and examination information were collected. Echocardiography including conventional cardiac ultrasound, tissue Doppler and two-dimensional speckle tracking to measure myocardial strain and noninvasive myocardial work were carried out , and the brachial-ankle pulse wave velocity was measured in parallel.
Other: Echocardiography and pulse wave velocity measurement
Echocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
myocardial work
Time Frame: 2020.09-2021.01
myocardial work measured by non-invasive left ventricular pressure-strain loop（2D speckle tracking echocardiography method by using the GE Vivid E95 ultrasound system ）
2020.09-2021.01

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
brachial-ankle pulse wave velocity
Time Frame: 2020.09-2021.01
brachial-ankle pulse wave velocity measured by OMRON BP-203RPEIII arteriosclerosis detector
2020.09-2021.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chongqing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: QIN DUAN, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200910

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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