Effect of Heart Valve Replacement on Cheyne-Stokes Respiration (CSR)
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| First Received Date ICMJE | August 28, 2011 | ||||||||
| Last Updated Date | July 24, 2012 | ||||||||
| Start Date ICMJE | September 2010 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Changes of CSR index before and 3, 6, 12 months following valve replacement. [ Time Frame: 1 year after cardiac surgery of each enrolled patient ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE |
compare the changes of parameters of Cheyne-Stokes Respiration and heart function before heart valve replacement and 3, 6, and 12 months after the surgery. [ Time Frame: 1 year after surgery of each patient ] [ Designated as safety issue: Yes ] The primary goal of this study is to compare 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. |
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| Change History | Complete list of historical versions of study NCT01426776 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement [ Time Frame: 1 year after cardiac surgery of each enrolled patient ] [ Designated as safety issue: Yes ] 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).) |
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| Original Secondary Outcome Measures ICMJE |
determine the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases. [ Time Frame: 1 month after screening the 300th patient ] [ Designated as safety issue: No ] Observe the prevalence of Cheyne-Stokes respiration in patients with heart valve diseases and determine the risk factors of Cheyne-Stokes respiration in patients with heart valve diseases. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Heart Valve Replacement on Cheyne-Stokes Respiration | ||||||||
| Official Title ICMJE | Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: heart valve replacement
The patients with heart valve disease and CSR will be received heart valve replacement
Other Name: cardiac surgery |
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| Study Arm (s) | heart valve replacement
Intervention: Procedure: heart valve replacement |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 26 | ||||||||
| Completion Date | July 2012 | ||||||||
| Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01426776 | ||||||||
| Other Study ID Numbers ICMJE | 30971319, 20092801 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Zhang Xilong, Nanjing Medical University | ||||||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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