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

NCT06282822 | Not Yet Recruiting

• 1 other identifier: HFpEF-SWE
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Shear Wave Elastography; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Shear wave velocity

  Completed within 2 weeks of enrollment

Interventions

Transthoracic echocardiography OTHER

All enrolled patients underwent noninvasive transthoracic echocardiography.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with preserved ejection fraction

You may qualify if:

• Age ≥18 years old
• Clear epidemiological and population characteristics of HFpEF
• Symptoms and/or signs of heart failure
• Echocardiographic examination of LVEF≥50%
• 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
• HFpEF score ≥6 or HFA-PEFF score ≥5

You may not qualify if:

• Any one item per patient was excluded from the study:
• Arrhythmia.
• ischemic heart disease.
• Valvular heart disease or congenital heart disease with severe hemodynamic changes.
• History of pacemaker implantation or other cardiac surgery.
• Poor ultrasonic image quality cannot meet the parameter measurement and analysis.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: March 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02