Central Sleep ApneaNCT01414309
Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
An observational study of Central Sleep Apnea and Heart Failure, run by Respicardia, Inc. at 4 sites in 2 countries.
Trial summary
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, Heart Failure
- How many people
- 5 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Aug 2011to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)
- Age is greater than or equal to 18 years
- Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:
- AHI greater than or equal to 20
- greater than or equal to 50% of classified events of a central nature
- less than 20% of the total AHI comprised of obstructive apnea events
- Diagnosed chronic heart failure, with medications optimized and stable for at least 30 days prior to the screening PSG, or since the date of the earliest test used for baseline, whichever is longer. Optimal medications include: beta blockade, ACE-I or ARB and diuretics unless contraindicated or not considered medically necessary.
Who cannot join
- Current or intended use of any mask-based therapy for central sleep apnea
- Baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)
- History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study
- Unstable angina
- History of primary pulmonary hypertension
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- Currently enrolled in a non-observational (ie, interventional) clinical study that could confound the results of this study
- If subject has an implanted cardiac resynchronization device (CRT), it must have been implanted at least 3 months before enrollment; any other device must have been implanted at least 30 days prior to enrollment
- Life expectancy of less than 6 months
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Central MN Heart at St Cloud
Saint Cloud, Minnesota, 56303
Sleep Therapy & Research Center, Alamo
San Antonio, Texas, 78229
About this study
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients.
Read the detailed description
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).
- Conditions
- Central Sleep Apnea, Heart Failure
- Keywords
- Heart Failure, Central Sleep Apnea, Sleep Disordered Breathing, Cardiac Dysfunction
- Medical subject headings
- Sleep Apnea, Central, 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 |
|---|---|---|
| Observational patients | Heart Failure patients with moderate to severe central sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index and its components
The primary objective of the study is to determine the natural progression of central sleep apnea, using the apnea-hypopnea index (AHI) and its components evaluated at 6 months.
Measured: 6 months
Secondary outcomes (1)
Clinical status associated with sleep disordered breathing
- Epworth Sleepiness Scale
- Subject Global Assessment
- Quality of life as measured by Minnesota Living with Heart Failure Questionnaire
- HF Clinical Composite
- Six-minute hall walk
- NYHA Functional Class
- Echocardiographic measures of structure and function
- Subject medications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Change in company priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respicardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Germany, M.D., Study director, Respicardia, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414309
- Sponsor's protocol ID
- EP 1137
- Status last verified
- Jan 2015
- First submitted
- 9 Aug 2011
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
- ClinicalTrials.gov ID
- NCT01414309
- Acronym / sponsor ID
- EP 1137
- Conditions
- Central Sleep Apnea, Heart Failure
- Keywords
- Heart Failure, Central Sleep Apnea, Sleep Disordered Breathing, Cardiac Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in company priorities
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Respicardia, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Aug 2011 (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.
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF). The primary purpose of this study is to document the natural progression of moderate to severe CSA in heart failure patients.
Detailed description
This trial is a prospective, non-randomized observational study in heart failure patients with moderate to severe central sleep apnea (CSA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational patients | – | –Heart Failure patients with moderate to severe central sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- Subject is willing and able to comply with this protocol and has signed an IRB/MEC approved informed consent (as well as Privacy Protection Authorization in the United States)
- Age is greater than or equal to 18 years
- Known recent history of sleep disordered breathing of predominantly central origin, as evidenced by an overnight PSG with EEG and at least 4 hours of recording that was conducted within 60 days of enrollment and demonstrating the following characteristics:
- AHI greater than or equal to 20
- greater than or equal to 50% of classified events of a central nature
Key exclusion criteria (9 listed)
- Current or intended use of any mask-based therapy for central sleep apnea
- Baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Severe Chronic Obstructive Pulmonary Disease (COPD) (per GOLD classification system)
- History of cerebrovascular accident (CVA), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI), or any cardiac ablation procedure within the 3 months prior to the study
- Unstable angina
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
Apnea-hypopnea index and its components
Time frame: 6 months
The primary objective of the study is to determine the natural progression of central sleep apnea, using the apnea-hypopnea index (AHI) and its components evaluated at 6 months.
1 secondary outcome
Clinical status associated with sleep disordered breathing
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Change in company priorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Sponsor's websiteLink provided by the sponsor.
Related trials for Central Sleep Apnea
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Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
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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.
Robin Germany, M.D. study director
Respicardia, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sleep Apnea and Heart Failure, run by Respicardia, Inc. at 4 sites in 2 countries.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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 was stopped early (reason given: Change in company priorities). Results are not available in the source record.
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?
Apnea-hypopnea index and its components (time frame: 6 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 7 Jan 2015.