Chronic Heart FailureNCT01212705
Effect of Adaptive Servoventilation on Cardiac Function in Chronic Heart Failure and Cheyne-Stokes Respiration
A study testing Adaptive servoventilation in people with Chronic Heart Failure and Central Sleep Apnea, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Central Sleep Apnea, Cheyne-Stokes Respiration
- What is being tested?
- Adaptive servoventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 sitePoland
- Study dates
- Start not givento 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- chronic heart failure with ejection fraction ≤45%
- optimal medical treatment for at least 1 month
- 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.
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medicine
Warsaw, Szaserow 128, 04-141
About this study
Official title: Effect of Adaptive Servoventilation on Cardiac Function, Exercise Tolerance and Quality of Life in Patients With Chronic Heart Failure and Cheyne-Stokes Respiration
Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.
- Being tested
- Adaptive servoventilation
- Medical subject headings
- Sleep Apnea, Central, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive servoventilationDevice
Background expiratory positive airway pressure with some inspiratory pressure support when needed
| Study group | Role | What they receive |
|---|---|---|
| ASV | Experimental | Not described Receives: Device: Adaptive servoventilation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Anna Kazimierczak, Principal investigator, Military Institute of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212705
- Sponsor's protocol ID
- BW2126/10
- Status last verified
- Sep 2010
- First submitted
- 30 Sep 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adaptive Servoventilation on Cardiac Function, Exercise Tolerance and Quality of Life in Patients With Chronic Heart Failure and Cheyne-Stokes Respiration
- ClinicalTrials.gov ID
- NCT01212705
- Acronym / sponsor ID
- BW2126/10
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- First posted
- 1 Oct 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.
Sleep disordered breathing is common in patients with chronic heart failure. Adaptive servoventilation is a novel method of treatment central sleep apnoea, especially associated with Cheyne-Stokes-respiration. The aim of the study is to investigate effect of adaptive servoventilation on cardiac function, exercise tolerance and quality of life in patients with chronic heart failure.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASV | Experimental | Device: Adaptive servoventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic heart failure with ejection fraction ≤45%
- optimal medical treatment for at least 1 month
- 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 |
|---|---|---|
| Adaptive servoventilationBackground expiratory positive airway pressure with some inspiratory pressure support when needed | Device | ASV |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2010.
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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.
Anna Kazimierczak principal investigator
Military Institute 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 servoventilation in people with Chronic Heart Failure and Central Sleep Apnea, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 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: status not confirmed, as of the sponsor's last update on 1 Oct 2010. 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 Poland. 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 Anna Kazimierczak (48 22 6818017, annakazimierczak@poczta.onet.pl), or a site near the patient. 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 1 Oct 2010.