Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

Heart Valve Disease Clinical Trial

— CSR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426776
• Other study ID #: 30971319
• Secondary ID: 20092801
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2020
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sleep Apnea
• Cheyne-Stokes Respiration
• Heart Valve Disease
• Heart Valve Diseases
• Sleep Apnea Syndromes
• Sleep Apnea, Central

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Abe H, Takahashi M, Yaegashi H, Eda S, Kitahara H, Tsunemoto H, Kamikozawa M, Koyama J, Yamazaki K, Ikeda U. Valve repair improves central sleep apnea in heart failure patients with valvular heart diseases. Circ J. 2009 Nov;73(11):2148-53. Epub 2009 Aug 28. — View Citation

Rubin AE, Gottlieb SH, Gold AR, Schwartz AR, Smith PL. Elimination of central sleep apnoea by mitral valvuloplasty: the role of feedback delay in periodic breathing. Thorax. 2004 Feb;59(2):174-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of CSR index before and 3, 6, 12 months following valve replacement.	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.	1 year after cardiac surgery of each enrolled patient
Secondary	Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement	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).)	1 year after cardiac surgery of each enrolled patient