Dilated CardiomyopathyNCT00282789
BiPAP for Cardiomyopathy With Central Sleep Apnea
A study testing bilevel positive airway pressure and bilevel positive airway pressure (Device) in people with Dilated Cardiomyopathy, run by Nagoya University at 1 site in Japan.
Trial summary
We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- bilevel positive airway pressure and bilevel positive airway pressure (Device)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Jun 2000to not given
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic dilated cardiomyopathy
Who cannot join
- a history of alcohol abuse, diabetes mellitus, endocrine disorders, hypertension, obstructive sleep apnea syndrome, and chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- bilevel positive airway pressure, bilevel positive airway pressure (Device)
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilevel positive airway pressureDevice
bilevel positive airway pressure (Device)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies 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)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Mitsuhiro Yokota, MD,PhD, Study chair, Department of Cardiovascular Genome Science, Nagoya University School of Medicine, Nagoya, Aichi, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282789
- Sponsor's protocol ID
- NU-06-A-0002
- Status last verified
- Jun 2000
- First submitted
- 26 Jan 2006
- Last updated
- 30 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiPAP for Cardiomyopathy With Central Sleep Apnea
- ClinicalTrials.gov ID
- NCT00282789
- Acronym / sponsor ID
- NU-06-A-0002
- Conditions
- Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Jun 2000
- First posted
- 27 Jan 2006 (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.
We investigated whether treatment of central sleep apnea-hypopnea with bilevel positive airway pressure (BiPAP) in patients with idiopathic dilated cardiomyopathy (IDCM) would improve LV function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic dilated cardiomyopathy
Key exclusion criteria (1 listed)
- a history of alcohol abuse, diabetes mellitus, endocrine disorders, hypertension, obstructive sleep apnea syndrome, and 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 |
|---|---|---|
| bilevel positive airway pressure | Device | – |
| bilevel positive airway pressure (Device) | Device | – |
Primary outcome
Not reported in the source record.
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 30 Jan 2006.
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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.
Mitsuhiro Yokota, MD,PhD study chair
Department of Cardiovascular Genome Science, Nagoya University School of Medicine, Nagoya, Aichi, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilevel positive airway pressure and bilevel positive airway pressure (Device) in people with Dilated Cardiomyopathy, run by Nagoya University 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 1 inclusion and 1 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 30 Jan 2006. 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.
Where can I read the original study information?
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 30 Jan 2006.