Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D STE

Left Ventricular Dysfunction Clinical Trial

Official title:

Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D Speckle-tracking Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957004
• Other study ID #: M2017397
• Status: Completed
• Start date: July 22, 2018
• Est. completion date: June 30, 2020

Study information

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

Clinical Trial Summary

The changes of left ventricular function in patients with sleep apnea were studied by three-dimensional speckle-tracking echocardiography to evaluate the changes of left ventricular function after CPAP treatment

Description:

Research purposes: (1) Use 3D speckle tracking echocardiography to measure the diastolic and systolic strains of the left atrium and left ventricle of OSAS patients, in order to evaluate the impact and degree of OSA on left ventricular function. (2) By comparing the changes in the three-dimensional ultrasound strain index of the left ventricle of patients before and after CPAP treatment, and in patients receiving and not receiving CPAP treatment, to evaluate whether CPAP treatment contributes to the improvement of cardiac function in patients with OSAS, and to infer the best suitable intervention population and using time, providing reference basis for clinical treatment. (3) Discovery of serological indicators that predict the severity of the disease and predict the impairment of heart function Study design: This study is a prospective, observational controlled study. It is planned to include 30 cases of newly diagnosed OSAS patients in the Peking University Third Hospital and a control group selected according to age and gender matching. The three-dimensional strain of the left atrium and left ventricle of the crowd is measured by the 3D speckle tracking technology, and the serological indicators are detected. The OSAS group and the control group were followed up during the course of receiving or not receiving CPAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: December 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014

2. Between the ages of 18 and 80, regardless of gender

3. Sign informed consent

Exclusion Criteria:

1. previously diagnosed patients with heart failure,

2. coronary artery disease,

3. valvular disease,

4. cardiomyopathy,

5. arrhythmia,

6. chronic obstructive/ restrictive pulmonary disease,

7. thyroid dysfunction (including hypothyroidism or hyperthyroidism),

8. already treated with CPAP,

9. poor image quality of echocardiography.

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• OSA
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Device:
• CPAP
CPAP ventilator was worn at nigh

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	The changes of echocardiographic and serological indexes were observed by 3D speckled tracking during the 1-year follow-up	The changes of echocardiographic indexs such as left ventricular three-dimensional strain and serological indexes including adiponectin.	The follow-up period was 1 year