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

Completed

• Conditions: OSA; Left Ventricular Dysfunction
• Interventions: Device: CPAP

• Registration Number: NCT04957004
• Lead Sponsor: Peking University Third Hospital

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-07-22
• Primary Completion: 2019-12-22
• Study Completion: 2020-06-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA patients	CPAP	Patients with OSA who have not been treated with CPAP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China