Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction

February 21, 2024 updated by: Chunyan Ma, First Hospital of China Medical University

Multimodal Ultrasound Radiomics Based on Shear Wave Elastography for Accurate Diagnosis of Heart Failure With Preserved Ejection Fraction: A Prospective Multicenter Study

The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with heart failure with preserved ejection fraction

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. Clear epidemiological and population characteristics of HFpEF
  3. Symptoms and/or signs of heart failure
  4. Echocardiographic examination of LVEF≥50%
  5. Objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction and/or elevated left ventricular filling pressure, including elevated levels of natriuretic peptides
  6. HFpEF score ≥6 or HFA-PEFF score ≥5

Exclusion Criteria:

Any one item per patient was excluded from the study:

  1. Arrhythmia.
  2. ischemic heart disease.
  3. Valvular heart disease or congenital heart disease with severe hemodynamic changes.
  4. History of pacemaker implantation or other cardiac surgery.
  5. Poor ultrasonic image quality cannot meet the parameter measurement and analysis.

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
Time Frame
Shear wave velocity
Time Frame: Completed within 2 weeks of enrollment
Completed within 2 weeks of enrollment

Collaborators and Investigators

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

Sponsor

First Hospital of China 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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFpEF-SWE

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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