Clinical trial NCT06282822: Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction
Official title: Multimodal Ultrasound Radiomics Based on Shear Wave Elastography for Accurate Diagnosis of Heart Failure With Preserved Ejection Fraction: A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shear Wave Elastography
Heart Failure With Preserved Ejection Fraction
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure with preserved ejection fraction

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Shear wave velocity
timeFrame: Completed within 2 weeks of enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: