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

Primary Purpose

Cheyne-Stokes Respiration, Heart Valve Disease, Central Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
heart valve replacement
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cheyne-Stokes Respiration focused on measuring Cheyne-Stokes respiration, Heart valve disease, Central Sleep Apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

heart valve replacement

Arm Description

a normal surgery that rheumatic valvular heart disease patients received.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).)

Full Information

First Posted
August 28, 2011
Last Updated
February 23, 2020
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01426776
Brief Title
Effect of Heart Valve Replacement on Cheyne-Stokes Respiration
Acronym
CSR
Official Title
Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cheyne-Stokes Respiration, Heart Valve Disease, Central Sleep Apnea
Keywords
Cheyne-Stokes respiration, Heart valve disease, Central Sleep Apnea

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heart valve replacement
Arm Type
Other
Arm Description
a normal surgery that rheumatic valvular heart disease patients received.
Intervention Type
Procedure
Intervention Name(s)
heart valve replacement
Other Intervention Name(s)
cardiac surgery
Intervention Description
The patients with heart valve disease and CSR will be received heart valve replacement
Primary Outcome Measure Information:
Title
Changes of CSR index before and 3, 6, 12 months following valve replacement.
Description
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.
Time Frame
1 year after cardiac surgery of each enrolled patient
Secondary Outcome Measure Information:
Title
Association of PSG parameters with cardiac function before and 3, 6, 12 months following valve replacement
Description
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).)
Time Frame
1 year after cardiac surgery of each enrolled patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shijiang Zhang, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ning Ding, Doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
19713650
Citation
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. doi: 10.1253/circj.cj-09-0307. Epub 2009 Aug 28.
Results Reference
background
PubMed Identifier
14760162
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. doi: 10.1136/thorax.2003.007799.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
published article
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/24938583
Available IPD/Information Identifier
PMID: 24938583
Available IPD/Information Comments
We found central sleep apnea was eliminated after cardiac valve replacement surgery, however, there was no change in obstructive sleep apnea.

Learn more about this trial

Effect of Heart Valve Replacement on Cheyne-Stokes Respiration

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