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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04957004
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 23.3
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
OSA; Left Ventricular Dysfunction	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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Evaluation of Left Ventricular Function and Therapeutic Effect of CPAP in Patients With OSAS by 3D Speckle-tracking Echocardiography
• Actual Study Start Date: Jul 22, 2018
• Actual Primary Completion Date: Dec 22, 2019
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Principal Investigator: Yongzhen Zhang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04957004
• Other Study ID Numbers: M2017397
• First Posted: Jul 9, 2021
• Last Update Posted: Jul 9, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peking University Third Hospital: OSA; CPAP; left ventricular dysfunction
• Additional relevant MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left

Study Results

No Results Posted as of Jul 9, 2021