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

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ClinicalTrials.gov Identifier: NCT01426776
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : July 25, 2012
Sponsor:
Information provided by (Responsible Party):

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
Cheyne-Stokes Respiration Heart Valve Disease Central Sleep Apnea Procedure: heart valve replacement

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  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
Study Start Date : September 2010
Primary Completion Date : February 2012
Study Completion Date : July 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
heart valve replacement Procedure: heart valve replacement
The patients with heart valve disease and CSR will be received heart valve replacement
Other Name: cardiac surgery


Outcome Measures

Primary Outcome Measures :
  1. Changes of CSR index before and 3, 6, 12 months following valve replacement. [ Time Frame: 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 :
  1. 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 ]
    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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426776


Locations
China, Jiangsu
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
More Information

Publications:
Responsible Party: Zhang Xilong, Department of Respirology, The First Affiliated Hospital of Nanjing Medical University, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01426776     History of Changes
Other Study ID Numbers: 30971319
20092801 ( Other Identifier: Ethic committee )
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Zhang Xilong, Nanjing Medical University:
Cheyne-Stokes respiration
Heart valve disease
Central Sleep Apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Heart Valve Diseases
Sleep Apnea, Central
Cheyne-Stokes Respiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms