Hypertension; Heart Disease, HypertensiveNCT05062811
Effect of Blood Pressure on Myocardial Work in Patients With Hypertension
An observational study of Hypertension; Heart Disease, Hypertensive, run by Chongqing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension; Heart Disease, Hypertensive
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 1.patients of outpatient clinic 2.65≥Adult aged ≥18years old;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Hypertension, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Global work index
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
Measured: On admission
Global constructed work
Global constructive work represented the sum of positive work due to myocardial shortening during systole and negative work due to lengthening during isovolumic relaxation.
Measured: On admission
Global longitudinal strain
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.
Measured: On admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Sep 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension; Heart Disease, HypertensiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongying Zhang, Chongqing Medical University
- Investigators
- Dongying Zhang, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062811
- Sponsor's protocol ID
- MW-China2021
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Blood Pressure and Myocardial Work in Patients With Different Levels of Blood Pressure
- ClinicalTrials.gov ID
- NCT05062811
- Acronym / sponsor ID
- MW-China2021
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1.patients of outpatient clinic 2.65≥Adult aged ≥18years old;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongying Zhang study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension; Heart Disease, Hypertensive, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongying Zhang (+8613608398395, zdy.chris@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global work index (time frame: On admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.