Effect of Heart Valve Replacement on Cheyne-Stokes Respiration (CSR)

Nanjing Medical University

Status: Completed

Conditions: Cheyne-Stokes Respiration; Central Sleep Apnea; Heart Valve Disease

Treatments: Procedure: heart valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT01426776

30971319

20092801 (Other Identifier)

Details and patient eligibility

About

Sleep disordered breathing, especially central sleep apnea, is common in patients with chronic heart failure. Heart valve replacement could have some effect on central sleep apnea. The aim of the study is to investigate effect of heart valve replacement on Cheyne-Stokes respiration in patients with rheumatic heart disease.

Full description

Sleep apnea, especially central sleep apnea, has a high prevalence in patients with chronic heart failure. Although sleep disordered breathing (SDB) have been described in patients with heart disease, the prevalence is not known because: ①There are various forms of SDBs, including obstructive sleep apnea(OSA), central sleep apnea (CSA), and mixed forms of sleep apnea syndromes that have variable prevalence; ②Patients suffering from rheumatic valve disease usually have varying degrees of heart failure, and this variability affects estimates of prevalence; ③There are no international patient registries and SDB is underdiagnosed in many parts of the world.

The previous studies are most focusing on nonvalvular disease. We ①investigate the prevalence and the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases, ②compare the changes of parameters of Cheyne-Stokes Respiration and heart function (like apnea hypopnea index, pulse oxygen saturation, blood pressure, echocardiogram, electrocardiogram, 6-minute walk test) before heart valve replacement and 3, 6, and 12 months after the surgery.

With nocturnal polysomnography (PSG) examination 30 patients typical CSR are going to be screened out from 300 patients with heart valve disease and waiting for cardiac surgery. The Comparison of 30 patients undergoing heart valve replacement will be performed before and 3, 6, and 12 months following heart valve replacement. We shall analyze the changes of CSR before and after valve replacement as well as the correlation among cardiac function and PSG parameters.

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• heart valve disease with any ejection fraction
• clinical diagnosis of Cheyne-Stokes respiration

Exclusion criteria

• unstable heart failure
• stroke
• transient ischemic attack in last 6 months
• pacemaker, cardioverter-defibrillator or resynchronization device implanted less than 6 months before study entrance
• severe chronic obstructive pulmonary disease

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

heart valve replacement

Other group

Description:

a normal surgery that rheumatic valvular heart disease patients received.

Treatment:

Procedure: heart valve replacement