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

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

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

Study Overview

• Status: Completed
• Conditions: OSA; Left Ventricular Dysfunction
• Intervention / Treatment: Device: CPAP

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 Type: Observational
• Enrollment (Actual): 60

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: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with OSA who underwent sleep monitoring at the Sleep Medicine Center of Peking University Third Hospital were selected for the study.OSA met the diagnostic criteria of obstructive sleep apnea in the United States Classification of Sleep Diseases in 2014.Exclusion criteria from this study included previously diagnosed patients with heart failure,coronary artery disease,valvular disease,cardiomyopathy,arrhythmia,chronic obstructive/ restrictive pulmonary disease, thyroid dysfunction (including hypothyroidism or hyperthyroidism), already treated with CPAP, and poor image quality of echocardiography. Healthy subjects who underwent sleep monitoring to exclude OSA were selected as the control group during the same period.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA patients; Patients with OSA who have not been treated with CPAP	Device: CPAP; CPAP ventilator was worn at nigh
control group; health control except OSA by using sleep monitorin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Yongzhen Zhang, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2018
• Primary Completion (Actual): December 22, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: OSA; CPAP; left ventricular dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: M2017397

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