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

NCT04949997 | Completed

• 1 other identifier: IRB00006761-M2017152
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

median ejection fraction; 3D-STI

Outcome Measures

Primary Outcomes (1)

• 3D-STI measurement indexes

  strain values of different sections from 3D-STI

  one week

Study Arms (2)

control

patients without heart failure

HF

patients with heart failure

Other: diagnose

Interventions

diagnose OTHER

HF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction.

HF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 2, 2021
• Study Start: October 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: May 31, 2019
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)