Hypertension; Heart Disease, HypertensiveNCT04573257
Effect of Aterial Stiffness 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.Exploring the early changes and mechanisms of left ventricular cardiac function caused by hypertension, and to… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension; Heart Disease, Hypertensive
- What is being tested?
- Echocardiography and pulse wave velocity measurement
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to Mar 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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%
Who cannot join
- coronary atherosclerotic heart disease or symptoms of angina
- Cardiomyopathy
- Valvular heart disease
- Diabetes
- Atrial fibrillation
- Renal function damage
Show all 9Show fewer
- Pregnancy
- Secondary hypertension
- Chemotherapy for malignant tumors
Trial locations and contacts
1 site in 1 country.
QIAN DUAN contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400000
Dongying Zhang, doctor, +8613608398395, zdy.chris@qq.com
Qin DUAN, +861862349865, 570549500@qq.com
About this study
Official title: 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.
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 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.
- Being tested
- Echocardiography and pulse wave velocity measurement
- Keywords
- two-dimensional speckle tracking, hypertension, aterosclerosis, myocardial work
- Medical subject headings
- Hypertension, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography and pulse wave velocity measurementOther
Echocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Echocardiography 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. Receives: Other: Echocardiography 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. Receives: Other: Echocardiography and pulse wave velocity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial work
myocardial work measured by non-invasive left ventricular pressure-strain loop（2D speckle tracking echocardiography method by using the GE Vivid E95 ultrasound system ）
Measured: 2020.09-2021.01
Secondary outcomes (1)
brachial-ankle pulse wave velocity
brachial-ankle pulse wave velocity measured by OMRON BP-203RPEIII arteriosclerosis detector
Measured: 2020.09-2021.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start10 Sep 2020
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 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
- QIN DUAN, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04573257
- Sponsor's protocol ID
- 20200910
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan Q, Ge P, Tao Y, Liao KL, Yang Y, Dong Q. Correlation between Ventricular-Arterial Coupling and Global Longitudinal Strain People with Hypertension With Preserved Ejection Fraction. Am J Hypertens. 2026 Feb 1;39(2):263-271. doi: 10.1093/ajh/hpaf153.
PubMed 41092222
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Arteriosclerosis and Myocardial Work in Hypertensive Patients With Left Ventricular Ejection Fraction Retention
- ClinicalTrials.gov ID
- NCT04573257
- Acronym / sponsor ID
- 20200910
- Keywords
- two-dimensional speckle tracking, hypertension, aterosclerosis, myocardial work
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 Oct 2020 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normotensive group | – | Other: Echocardiography and pulse wave velocity measurementThe 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. |
| Prehypertension group | – | Other: Echocardiography and pulse wave velocity measurementThe 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. |
| hypertensive group | – | Other: Echocardiography and pulse wave velocity measurementThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- coronary atherosclerotic heart disease or symptoms of angina
- Cardiomyopathy
- Valvular heart disease
- Diabetes
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography and pulse wave velocity measurementEchocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement | Other | Prehypertension group, hypertensive group, normotensive group |
Primary outcome
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 ）
1 secondary outcome
brachial-ankle pulse wave velocity
Time frame: 2020.09-2021.01
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 41092222Duan Q, Ge P, Tao Y, Liao KL, Yang Y, Dong Q. Correlation between Ventricular-Arterial Coupling and Global Longitudinal Strain People with Hypertension With Preserved Ejection Fraction. Am J Hypertens. 2026 Feb 1;39(2):263-271. doi: 10.1093/ajh/hpaf153.
Related trials for Hypertension; Heart Disease, Hypertensive
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingPhase 2
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
Hypertension
Active, not recruiting
Eliminating Severe Maternal Morbidity With Heart Health Doulas Trial
Preeclampsia, Hypertensive Disorder of Pregnancy
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.
QIAN DUAN contact
QIN DUAN principal investigator
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 4 inclusion and 9 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 5 Oct 2020. 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 QIN DUAN (8618623349865, 570549500@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial work (time frame: 2020.09-2021.01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04573257, which also lists 1 linked publication.
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 5 Oct 2020.