The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients

October 15, 2020 updated by: Dongying Zhang, Chongqing Medical University

The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in Heart Failure With Preserved Ejection Fraction Patients

Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between blood pressure and arterial stiffness in HFpEF patients with different levels of obesity.

Study Overview

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

      • Chongqing, China
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Heart failure patients with preserved ejection fraction (HFpEF)

Description

Inclusion Criteria:

  • Adult aged >=18years old;
  • Diagnosed with HFpEF.

Diagnostic criteria including:

  1. left ventricular ejection fraction ≥50%;
  2. with the symptoms and/or signs of heart failure;
  3. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  4. 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

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

Outcome Measure
Measure Description
Time Frame
Arterial stiffness
Time Frame: On admission
The arterial stiffness of HFpEF patients, for example brachial ankle pulse wave velocity, ardioankle vascular index and so on.
On admission
Epicardial Fat Tissue
Time Frame: On admission
Epicardial Fat Tissue by cardiac color Doppler ultrasound
On admission

Collaborators and Investigators

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

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)

September 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

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)?

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.

Clinical Trials on Heart Failure With Preserved Ejection Fraction

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