Heart FailureNCT00725595
Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
An observational study of Heart Failure and Sleep Apnea, run by Nanjing Medical University at 1 site in China.
Trial summary
The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Sleep Apnea
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Dec 2008
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with both CSR and heart failure
Who may be able to join
- Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
- Subject is > 18 years old
- Patients with known history of CSR. CSR symptoms may include the following:
- sleep fragmentation as reported by patient or as witnessed by another person
- night arousal after apneic episodes
- reduced exercise capacity
- daytime sleepiness
- Expected to tolerate the ventilator therapy
Who cannot join
- Baseline oxygen saturation < 90% on a stable FIO2)
- Patient is currently enrolled in another clinical study which may confound the results of this study
- Patient for whom informed consent cannot be obtained
- Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
- Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
- Patients with severe COPD (per GOLD scale)
- Patients with a history of myocardial infarction within the 6 months prior to the study
- Patients with unstable angina
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 1st Affiliated Hospitak of Nanjing Medical University
Nanjing, Jiangsu, 210029
Wang Hong, PhD, 86-83714511 ext. 6705, zhsj_wh@hotmail.com
Zhang Shijiang, MD
About this study
The overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.
- Conditions
- Heart Failure, Sleep Apnea
- Keywords
- Cheyne Stocks respiration, heart failure, sleep apnea, ventilator
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| E, 2, III | To treat CSR with ASV and Bilevel ventilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Both ASV and Bilevel ventilation are effective in clinical treatment of CSR
Measured: three months
Secondary outcomes (1)
ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure
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 posted30 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
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 Heart FailureStudies 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
- Observational
- Observational model
- Case only
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725595
- Sponsor's protocol ID
- 092801
- Other IDs
- 20070928, No 092801
- Status last verified
- Aug 2008
- First submitted
- 28 Jul 2008
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang XL, Yin KS, Jiang SS, Li XL, Jia EZ, Su M. [Efficacy of adaptive pressure support servo-ventilation in patients with congestive heart failure and Cheyne-Stokes respiration]. Zhonghua Yi Xue Za Zhi. 2006 Jun 20;86(23):1620-3. Chinese.
PubMed 16854301
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cheyne Stocks Respiration With Adaptive Servo Ventilation and Bilevel Ventilators in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00725595
- Acronym / sponsor ID
- 092801
- Conditions
- Heart Failure, Sleep Apnea
- Keywords
- Cheyne Stocks respiration, heart failure, sleep apnea, ventilator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 30 Jul 2008 (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 overall purpose of this study is to determine the effects of adaptive servo ventilation (ASV) and bi-level ventilators on Cheyne-Stocks respiration (CSR). CSR is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. Clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. The intent of the proposed intervention is to compare the efficacies of ASV and Bi-level ventilator on CSR.
Study design
- Observational model
- Case only
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E, 2, III | – | –To treat CSR with ASV and Bilevel ventilators |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with both CSR and heart failure
Key inclusion criteria (8 listed)
- Patient or legal representative of the patient is willing and able to sign an IRB/MEC approved informed consent and Privacy Protection Authorization in the United States
- Subject is > 18 years old
- Patients with known history of CSR. CSR symptoms may include the following:
- Expected to tolerate the ventilator therapy
Key exclusion criteria (8 listed)
- Baseline oxygen saturation < 90% on a stable FIO2)
- Patient is currently enrolled in another clinical study which may confound the results of this study
- Patient for whom informed consent cannot be obtained
- Patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure
- Patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Both ASV and Bilevel ventilation are effective in clinical treatment of CSR
Time frame: three months
1 secondary outcome
ASV treatment is more effective in removal or reduction of Cheyne-Stocks respiration than Bilevel ventilator for patients with chronic heart failure
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2008.
- Results publication: PubMed 16854301Zhang XL, Yin KS, Jiang SS, Li XL, Jia EZ, Su M. [Efficacy of adaptive pressure support servo-ventilation in patients with congestive heart failure and Cheyne-Stokes respiration]. Zhonghua Yi Xue Za Zhi. 2006 Jun 20;86(23):1620-3. Chinese.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sleep Apnea, 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 8 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: status not confirmed, as of the sponsor's last update on 26 Aug 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Xilong, PhD (96-25-83714511 ext. 6723, zhangxilong1952@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Both ASV and Bilevel ventilation are effective in clinical treatment of CSR (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 NCT00725595, 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 26 Aug 2008.