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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04949997
Other study ID # IRB00006761-M2017152
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 31, 2019

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date May 31, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 3D-STI measurement indexes strain values of different sections from 3D-STI one week
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