Heart Failure3CNCT00563693
Chronic Heart Failure - Cheyne Stokes Respiration - CS2 (3C-study)
A study testing ASV and without Autoset CS2 in people with Heart Failure and Cheyne Stokes Respiration, run by University of Oslo at 1 site in Norway.
Trial summary
An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Cheyne Stokes Respiration
- What is being tested?
- ASV and without Autoset CS2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to Jan 2011
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ejection fraction <40%
- NYHA class III-IV
- Optimized therapy with drugs
- Cheyne stokes respiration pattern > 25% while sleeping
- Age < 85 years
- clinical stability the last month before inclusion.
Who cannot join
- CABG less then 6 months ago
- PCI treatment less then 3 months ago
- Unstable angina pectoris
- Acute coronary syndrome less then 3 months ago
- Stroke less then 6 weeks ago
- Thoracal myopathy
- Advanced COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).
An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.
Read the detailed description
Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.
Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.
- Conditions
- Heart Failure, Cheyne Stokes Respiration
- Being tested
- ASV, without Autoset CS2
- Keywords
- heart failure, cheyne stokes respiration, adaptive servo ventilator
- Medical subject headings
- Heart Failure, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASVDevice
Also called AutoSet CS2
Adaptive servo ventilator
without Autoset CS2Other
without Autoset CS2
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | The patients use ASV Receives: Device: ASV; Other: without Autoset CS2 |
| B | Active comparator | Patients without ASV Receives: Other: without Autoset CS2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction (measured with echocardiography) and inflammatory markers
Measured: 3 months
Secondary outcomes (1)
6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Arild Hetland, University of Oslo
- Investigators
- Arild Hetland, cardiologist, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563693
- Sponsor's protocol ID
- 1.2007.980
- Acronym
- 3C
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2007
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Study of Patients With Chronic Heart Failure and Cheyne Stokes Respiration Pattern, Treated With ASV. (Adaptive Servo Ventilator).
- ClinicalTrials.gov ID
- NCT00563693
- Acronym / sponsor ID
- 3C / 1.2007.980
- Conditions
- Heart Failure, Cheyne Stokes Respiration
- Keywords
- heart failure, cheyne stokes respiration, adaptive servo ventilator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Sep 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 26 Nov 2007 (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.
An investigation where patients with chronic heart failure and cheyne stokes respiration, treated with adapitve servo ventilator, will improve their cardiac function and quality of life.
Detailed description
Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine.
Several patients with chronic heart failure also has Cheyne Stokes respiration pattern. Earlier studies have shown that this respiration pattern improves with Adaptive servo ventilator. We wish to investigate wether this leads to improved cardiac function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: ASV, Other: without Autoset CS2The patients use ASV |
| B | Active comparator | Other: without Autoset CS2Patients without ASV |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ejection fraction <40%
- NYHA class III-IV
- Optimized therapy with drugs
- Cheyne stokes respiration pattern > 25% while sleeping
- Age < 85 years
Key exclusion criteria (7 listed)
- CABG less then 6 months ago
- PCI treatment less then 3 months ago
- Unstable angina pectoris
- Acute coronary syndrome less then 3 months ago
- Stroke less then 6 weeks ago
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 |
|---|---|---|
| ASVAlso: AutoSet CS2Adaptive servo ventilator | Device | A |
| without Autoset CS2without Autoset CS2 | Other | A, B |
Primary outcome
Ejection fraction (measured with echocardiography) and inflammatory markers
Time frame: 3 months
1 secondary outcome
6 minutes walking test Quality of life Changes in cathecolamines Altered frequency of arrythmias
Time frame: 3 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 3 Dec 2015.
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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.
Arild Hetland, cardiologist principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASV and without Autoset CS2 in people with Heart Failure and Cheyne Stokes Respiration, run by University of Oslo at 1 site in Norway.
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 6 inclusion and 7 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 3 Dec 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 Norway. 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?
Ejection fraction (measured with echocardiography) and inflammatory markers (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 3 Dec 2015.