Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

Not Applicable

Completed

• Conditions: Heart Valve Disease; Central Sleep Apnea; Cheyne-Stokes Respiration
• Interventions: Procedure: heart valve replacement

• Registration Number: NCT01426776
• Lead Sponsor: Nanjing Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-08-28
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Primary Completion: 2012-02
• Study Completion: 2012-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-23
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
heart valve replacement	heart valve replacement	a normal surgery that rheumatic valvular heart disease patients received.

Primary Outcome Measures

Name	Time	Method
Changes of CSR index before and 3, 6, 12 months following valve replacement.	1 year after cardiac surgery of each enrolled patient	The primary goal of this study is to compare the changes of polysomnography(PSG) parameters(index of CSR, apnea hypopnea index, pulse oxygen saturation, etc)before and 3, 6, 12 months following the cardiac valve replacement surgery.

Secondary Outcome Measures

Name	Time	Method
Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement	1 year after cardiac surgery of each enrolled patient	The secondary goal of this study is to determine the association of PSG parameters(index of CSR, apnea hypopnea index, pulse oxygen saturation, electrocardiogram, etc)and cardiac function (LVEF, 6-minute walk test, etc) before and 3, 6, 12 months following the cardiac valve replacement surgery. Qualities of life and sleep will also be masured before and 3, 6, 12 months after surgery. (The quality of life is assessed by reference to "The Medical Outcomes Study 36item Short-Form Health Survey"(SF-36) generic questionnaire, and sleep quality is assessed by Pittsburgh Sleep Quality Index(PSQI).)

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China