Cheyne-Stokes RespirationCSRNCT01426776
Effect of Heart Valve Replacement on Cheyne-Stokes Respiration
A study testing heart valve replacement in people with Cheyne-Stokes Respiration and Heart Valve Disease, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cheyne-Stokes Respiration, Heart Valve Disease, Central Sleep Apnea
- What is being tested?
- heart valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- heart valve disease with any ejection fraction
- clinical diagnosis of Cheyne-Stokes respiration
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
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.
Read the 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.
- Being tested
- heart valve replacement
- Keywords
- Cheyne-Stokes respiration, Heart valve disease, Central Sleep Apnea
- Medical subject headings
- Cheyne-Stokes Respiration, Heart Valve Diseases, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart valve replacementProcedure or surgery
Also called cardiac surgery
The patients with heart valve disease and CSR will be received heart valve replacement
| Study group | Role | What they receive |
|---|---|---|
| heart valve replacement | Other | a normal surgery that rheumatic valvular heart disease patients received. Receives: Procedure: heart valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after cardiac surgery of each enrolled patient
Secondary outcomes (1)
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).)
Measured: 1 year after cardiac surgery of each enrolled patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cheyne-Stokes RespirationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xilong, Nanjing Medical University
- Investigators
- Shijiang Zhang, MD, Study director, The First Affiliated Hospital with Nanjing Medical UniversityNing Ding, Doctor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426776
- Sponsor's protocol ID
- 30971319
- Other IDs
- 20092801
- Acronym
- CSR
- Status last verified
- Feb 2020
- First submitted
- 28 Aug 2011
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19713650Rubin 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.
PubMed 14760162
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heart Valve Replacement on Cheyne-Stokes Respiration in Patients With Rheumatic Heart Disease
- ClinicalTrials.gov ID
- NCT01426776
- Acronym / sponsor ID
- CSR / 30971319
- Keywords
- Cheyne-Stokes respiration, Heart valve disease, Central Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heart valve replacement | Other | Procedure: heart valve replacementa normal surgery that rheumatic valvular heart disease patients received. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- heart valve disease with any ejection fraction
- clinical diagnosis of Cheyne-Stokes respiration
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heart valve replacementAlso: cardiac surgeryThe patients with heart valve disease and CSR will be received heart valve replacement | Procedure or surgery | heart valve replacement |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Background: PubMed 19713650Abe 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 publication: PubMed 14760162Rubin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shijiang Zhang, MD study director
The First Affiliated Hospital with Nanjing Medical University
Ning Ding, Doctor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart valve replacement in people with Cheyne-Stokes Respiration and Heart Valve Disease, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of CSR index before and 3, 6, 12 months following valve replacement. (time frame: 1 year after cardiac surgery of each enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.