CSR: Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

Sponsor

Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT01426776

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cheyne-Stokes Respiration Heart Valve Disease Central Sleep Apnea	Procedure: heart valve replacement	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: heart valve replacement a normal surgery that rheumatic valvular heart disease patients received.	Procedure: heart valve replacement The patients with heart valve disease and CSR will be received heart valve replacement Other Names: cardiac surgery

Arm

Intervention/Treatment

Other: heart valve replacement

a normal surgery that rheumatic valvular heart disease patients received.

Procedure: heart valve replacement

The patients with heart valve disease and CSR will be received heart valve replacement

Other Names:

cardiac surgery

Outcome Measures

Primary Outcome Measures

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

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).)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director: Shijiang Zhang, MD, The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Ning Ding, Doctor, The First Affiliated Hospital with Nanjing Medical University