Chronic Heart FailureNCT01187823
The Effect of Adaptive Servo Ventilation and Oxygen Therapy in Central Sleep Apnea Patients
A study testing Adaptive servo ventilation and Nocturnal oxygen in people with Chronic Heart Failure and Sleep Apnea, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Sleep Apnea
- What is being tested?
- Adaptive servo ventilation and Nocturnal oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Mar 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction<50% confirmed by echocardiography
- Apnea hypopnea index(AHI)>=20 confirmed by overnight polysomnography
- More than 15% of AHI is due to CSA
Who cannot join
- Changes of cardioactive drug prescriptions within 6 weeks
- Admission due to cardiovascular events within 6 weeks
- Ever used CPAP or ASV for sleep apnea
- Ever used nocturnal oxgen therapy
- Subjects with acute exacerbation of chronic heart failure
- Operation for upper airway within 90 days
- Renal dialysis
- History of stroke with neurological deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.
Read the detailed description
Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective modalities. However,in fact, majority of CHF patients are complicated not only with CSA but with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV function. The present study is prospective randomised study to compare the effects of nocturnal oxygen therapy and Bipap® auto SV Advanced.
- Conditions
- Chronic Heart Failure, Sleep Apnea
- Being tested
- Adaptive servo ventilation, Nocturnal oxygen
- Keywords
- Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive servo ventilationDevice
Also called Bipap® auto SV Advanced (Philips Respironics)
Nocturnal use of Adaptive servo ventilation
Nocturnal oxygenDevice
Nocturnal use of oxygen
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal oxygen therapy | Active comparator | Not described Receives: Device: Nocturnal oxygen |
| Adaptive servo ventilation | Active comparator | Bipap® auto SV Advanced Receives: Device: Adaptive servo ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction confirmed by echocardiography
Measured: three months
Secondary outcomes (8)
Sleep quality confirmed by polysomnography
Measured: three months
Endothelial function
Measured: three months
Sleepiness
Measured: three months
Blood pressure
Measured: three months
Serum biomarkers
Inflammation, oxidative stress
Measured: three months
health-related quality of life
Measured: three months
Urinary biomarkers
inflammation, oxidative stress
Measured: three months
Heart rate
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics, Philips Healthcare
- Responsible party
- Principal investigator, Kimihiko Murase, Kyoto University, Graduate School of Medicine
- Investigators
- Kazuo Chin, MD, PhD, Principal investigator, Kyoto University, Graduate School of MedicineTakeshi Kimura, MD,PhD, Principal investigator, Kyoto University, Graduate School of MedicineMIchiaki Mishima, MD,PhD, Study chair, Kyoto University, Graduate School of MedicineKimihiko Murase, MD, Principal investigator, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187823
- Sponsor's protocol ID
- C-447
- Status last verified
- Jul 2014
- First submitted
- 23 Aug 2010
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Murase K, Ono K, Yoneda T, Iguchi M, Yokomatsu T, Mizoguchi T, Izumi T, Akao M, Miki S, Nohara R, Ueshima K, Mishima M, Kimura T, White DP, Chin K. Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial. Open Heart. 2016 Mar 31;3(1):e000366. doi: 10.1136/openhrt-2015-000366. eCollection 2016.
PubMed 27099761
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adaptive Servo Ventilation(Bipap® Auto SV Advanced) and Oxgen Therapy in Chronic Heart Failure Patients Complicated With Central Sleep Apnea
- ClinicalTrials.gov ID
- NCT01187823
- Acronym / sponsor ID
- C-447
- Conditions
- Chronic Heart Failure, Sleep Apnea
- Keywords
- Chronic heart failure, Central sleep apnea, Obstructive sleep apnea, Adaptive servo ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Philips Respironics, Philips Healthcare
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Aug 2010 (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.
The aim of this study is to compare the effects of Adaptive Servo Ventilation (Bipap® auto SV Advanced) and oxygen therapy in chronic heart failure patients complicated with central sleep apnea.
Detailed description
Central sleep apnea(CSA) is associated with chronic heart failure(CHF). At present, both of nocturnal oxygen therapy and adaptive servo ventilation(ASV) are recognized as effective modalities. However,in fact, majority of CHF patients are complicated not only with CSA but with obstructive sleep apnea(OSA). Recently, Philips developed Bipap® auto SV Advanced for such patients. It has auto-CPAP function as the modality of OSAS, in addition to ASV function. The present study is prospective randomised study to compare the effects of nocturnal oxygen therapy and Bipap® auto SV Advanced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nocturnal oxygen therapy | Active comparator | Device: Nocturnal oxygen |
| Adaptive servo ventilation | Active comparator | Device: Adaptive servo ventilationBipap® auto SV Advanced |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction<50% confirmed by echocardiography
- Apnea hypopnea index(AHI)>=20 confirmed by overnight polysomnography
- More than 15% of AHI is due to CSA
Key exclusion criteria (8 listed)
- Changes of cardioactive drug prescriptions within 6 weeks
- Admission due to cardiovascular events within 6 weeks
- Ever used CPAP or ASV for sleep apnea
- Ever used nocturnal oxgen therapy
- Subjects with acute exacerbation of chronic heart failure
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 |
|---|---|---|
| Adaptive servo ventilationAlso: Bipap® auto SV Advanced (Philips Respironics)Nocturnal use of Adaptive servo ventilation | Device | Adaptive servo ventilation |
| Nocturnal oxygenNocturnal use of oxygen | Device | Nocturnal oxygen therapy |
Primary outcome
Left ventricular ejection fraction confirmed by echocardiography
Time frame: three months
8 secondary outcomes
Sleep quality confirmed by polysomnography
Time frame: three months
Endothelial function
Time frame: three months
Sleepiness
Time frame: three months
Blood pressure
Time frame: three months
Serum biomarkers
Time frame: three months
health-related quality of life
Time frame: three months
Urinary biomarkers
Time frame: three months
Heart rate
Time frame: three months
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 14 Apr 2015.
- Derived from this study: PubMed 27099761Murase K, Ono K, Yoneda T, Iguchi M, Yokomatsu T, Mizoguchi T, Izumi T, Akao M, Miki S, Nohara R, Ueshima K, Mishima M, Kimura T, White DP, Chin K. Adaptive servoventilation versus oxygen therapy for sleep disordered breathing in patients with heart failure: a randomised trial. Open Heart. 2016 Mar 31;3(1):e000366. doi: 10.1136/openhrt-2015-000366. eCollection 2016.
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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.
Kazuo Chin, MD, PhD principal investigator
Kyoto University, Graduate School of Medicine
Takeshi Kimura, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
MIchiaki Mishima, MD,PhD study chair
Kyoto University, Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive servo ventilation and Nocturnal oxygen in people with Chronic Heart Failure and Sleep Apnea, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
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 3 inclusion and 8 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 14 Apr 2015. 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 Japan. 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?
Left ventricular ejection fraction confirmed by echocardiography (time frame: three months). 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 NCT01187823, which also lists 1 linked publication.
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 14 Apr 2015.