- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06282822
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
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:
- 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
Exclusion Criteria:
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.
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.
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.
Clinical Trials on Heart Failure With Preserved Ejection Fraction
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
Istituti Clinici Scientifici Maugeri SpARecruitingHeart Failure With Preserved Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Zhijun SunEnrolling by invitationHeart Failure | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionChina
-
Corvia MedicalWithdrawnHeart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection Fraction
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Yale UniversityRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure NYHA Class IVUnited States
Clinical Trials on Transthoracic echocardiography
-
Kang YanRecruiting
-
University Hospital, GrenobleCompleted
-
Philipps University Marburg Medical CenterKerckhoff Heart CenterCompletedHemodynamic Instability During Anesthesia | High Risk SurgeryGermany
-
Lifetech Scientific (Shenzhen) Co., Ltd.RecruitingNon-valvular Atrial Fibrillation | Embolic StrokeChina
-
Queen Mary Hospital, Hong KongRecruitingAcute Hypoxemic Respiratory FailureHong Kong
-
Emergency Medical Service of the Central Bohemian...Masaryk Hospital Usti nad LabemUnknown
-
University of Lausanne HospitalsUnknown
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Centre Hospitalier Universitaire de NīmesRecruitingAnemia | Ultrasonography | Age ProblemFrance
-
University of Cape TownCompleted