Effect of Blood Pressure on Myocardial Work in Patients With Hypertension

September 21, 2021 updated by: Dongying Zhang, Chongqing Medical University

The Relationship Between Blood Pressure and Myocardial Work in Patients With Different Levels of Blood Pressure

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 the 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. Myocardial work analysis Echocardiography plays a central role in the evaluation of patients with cardiovascular disease. Echocardiography is widely available and allows characterization of the functional and structural of heart. Thus, assessment of left lentricular (LV) global longitudinal strain (LVGLS) and Myocardial work indexes has proven benefit for both diagnosis and risk in hypertension patients.

Study Overview

Status

Status

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

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.

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 the 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.Now days, Echocardiography plays a central role in the evaluation of patients with cardiovascular disease. Echocardiography is widely available and allows characterization of the functional and structural of heart. Thus, assessment of left lentricular (LV) global longitudinal strain (LVGLS) and Myocardial work indexes has proven benefit for both diagnosis and risk in hypertension patients. Myocardial work indexes have four indexes to evaluate different function of lentricular. However, there is still no research investigating the the relationship between blood pressure and Myocardial work indexes in patients with different levels of blood pressure.

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.
300

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

Study Locations

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

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hypertension patients evaluated by echocardiography in the Echocardiography Center of the First Affiliated Hospital of Chongqing Medical University from September 2021 to January 2022.

Description

Inclusion Criteria:

1.patients of outpatient clinic 2.65≥Adult aged ≥18years old;

Exclusion Criteria:

The exclusion criteria were patients aged less than 18 or greater than 65 years, previous diagnosis of diabetes mellitus, coronary artery disease, valve heart disease, primary cardiomyopathies, arterial fibrillation, left ventricular ejection fraction<50% , inadequate echocardiographic imaging. The patients with disease leading low PP(≤30mmHg) were special examined and excluded, including pericardial disease, severe mitral stenosis, aortic stenosis, severe chronic heart failure, blood loss and shock etc. A total of 40 patients were exclude from the study according to the preset criteria.

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

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
Global work index
Time Frame: On admission
Global work index by non-invasive pressure-strain loops: a novel parameter to assess left ventricular performance in the early stages of heart failure with preserved or mid-range ejection fraction after acute myocardial infarction
On admission
Global constructed work
Time Frame: On admission
Global constructive work represented the sum of positive work due to myocardial shortening during systole and negative work due to lengthening during isovolumic relaxation.
On admission
Global longitudinal strain
Time Frame: On admission
The assessment of global longitudinal strain (GLS) from speckle-tracking analysis of 2-dimensional echocardiography has become a clinically feasible alternative to LVEF for the measurement of myocardial function.
On admission

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.
  • Study Director: Dongying Zhang, 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 1, 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.
December 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.
December 1, 2022

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 14, 2021

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 21, 2021

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.
September 30, 2021

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.
September 30, 2021

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 21, 2021

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, 2021

More Information

Terms related to this study

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.
  • MW-China2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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