- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04594499
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction Patients
Study Overview
Status
Detailed Description
Heart failure with preserved ejection fraction (HFpEF) has typical symptoms and signs of heart failure with preserved ejection fraction (LVEF≥50%). Often associated with obesity, hyperlipidemia and other metabolic syndromes. At present, the incidence of HFpEF accounts for about 50% of heart failure, and it is increasing year by year. However, the specific pathogenesis of HFpEF is unknown, and there is a lack of effective diagnosis and treatment methods. A number of studies have shown that obesity is a unique pathophysiological phenotype of individuals with HFpEF, and the activation of inflammatory mediators is extremely prominent in the pathophysiological process of HFpEF. Therefore, we speculate that both obesity and inflammation are related to increased arterial stiffness.
Obesity is a heterogeneous disease. Certain ectopic fats, such as epicardial adipose tissue (EAT), may be related to obesity-related cardiovascular risks. EAT is a kind of visceral fat. Under pathological conditions, it releases factors harmful to the coronary artery and myocardium, and promotes the transition of EAT to a pro-inflammatory and pro-fibrotic phenotype. Brachial ankle pulse wave velocity (baPWV) is an indicator for evaluating arterial stiffness. It is a relatively simple, non-invasive method for detecting vascular compliance and an independent prediction of cardiovascular events in people without cardiovascular disease. Factors can be used to assess the risk of cardiovascular events. However, no relevant research has confirmed that pericardial fat can increase the arterial stiffness of HFpEF.
This study intends to observe the influence of pericardial fat on the arterial stiffness of HFpEF and explore the relationship between pericardial fat thickness and arterial stiffness of HFpEF, in order to assist the clinic in evaluating the vascular state of HFpEF patients faster and better, and to judge the prognosis. At the same time, EAT has the characteristics of fast metabolism, strong organ fat specificity, and simple measurement. It can also be used as a target for drug targeted therapy, opening up a new way for drug therapy of cardiometabolic diseases.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Chongqing, China
- Recruiting
- The First Affiliated Hospital of Chongqing Medical University
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Contact:
- 东营 Zhang
- Phone Number: +8613608398395
- Email: zdy.chris@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult aged >=18years old;
- Diagnosed with HFpEF.
Diagnostic criteria including:
- left ventricular ejection fraction ≥50%;
- with the symptoms and/or signs of heart failure;
- BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
- at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction
Exclusion Criteria:
- LVEF less than 45% at any time;
- Severe liver failure;
- Primary pulmonary hypertension;
- Age <18 years old.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Arterial stiffness
Time Frame: On admission
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The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.
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On admission
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Epicardial Fat Tissue
Time Frame: On admission
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Epicardial Fat Tissue by cardiac color Doppler ultrasound
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On admission
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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