Evaluation of Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging

Evaluation of Left Ventricular Systolic Function in Heart Failure With Middle Ejection Fraction by 3D Speckle Tracking Imaging

In 2016, the European Heart Association defined the median ejection fraction heart failure for the first time. More research is needed to improve our understanding of this population, so as to make the best clinical decision and improve the prognosis. In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: diagnose

Detailed Description

As the final manifestation of cardiovascular disease and the main cause of death, heart failure is one of the important challenges threatening human health in the 21st century. In 2016, the European Heart Association proposed a new classification standard for heart failure. In particular, for the first time, heart failure with median ejection fraction has been clearly defined. These patients have received more and more attention, but there are still relatively few studies on them. More research is needed to improve our understanding of this part of the population in order to make the best clinical decisions and improve the prognosis. 3D speckle tracking technology is a new technology developed on the basis of real-time three-dimensional echocardiography and speckle tracking technology. It is gradually recognized in the evaluation of left ventricular systolic and diastolic function, especially in the evaluation of cardiotoxicity of chemotherapy drugs. At present, the application of 3D-STI in the evaluation of left ventricular systolic function in heart failure with median ejection fraction is limited and needs further study.In this study, 3D-STI was used to evaluate left ventricular systolic function in heart failure with median ejection fraction.

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients meet the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for HF but not the exclusion criteria

Description

Inclusion Criteria:

Meeting the diagnostic and classification criteria of heart failure proposed in the 2016 ESC guidelines for the diagnosis and treatment of acute / chronic heart failure

Exclusion Criteria:

1. acute or chronic infectious diseases;
2. COPD, chronic bronchitis, emphysema and other serious lung diseases;
3. Autoimmune diseases;
4. Malignant tumor;
5. Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 3 times of normal value);
6. Acute and chronic kidney disease, end-stage renal disease (serum creatinine > 220 μmol/L, or creatinine clearance rate < 30 ml/min);
7. Heart valve disease;
8. Severe arrhythmia;
9. The image quality of echocardiography was poor when it was larger than three sections;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; patients without heart failure
HF; patients with heart failure	Other: diagnose; HF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D-STI measurement indexes	strain values of different sections from 3D-STI	one week

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: median ejection fraction; 3D-STI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IRB00006761-M2017152

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