Acute Decompensated Heart FailureNCT02440971
Adaptive Servo Ventilation (ASV) in Heart Failure
An observational study of Acute Decompensated Heart Failure and Sleep Disordered Breathing, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial summary
Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure, Sleep Disordered Breathing
- What is being tested?
- S9-Autoset CS-A
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- May 2013to Sep 2019
- 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: Patients admitted into hospital for acute management of ADHF are eligible to participate in this study (providing inclusion/exclusion criteria are met)
Who may be able to join
- Admitted to the hospital with a primary diagnosis of ADHF
- Stable off oxygen for 24 hours
- Informed consent
- Age ≥ 18 years
Who cannot join
- Age < 18 years
- Pregnant women, breastfeeding mothers
- Anyone not capable of giving informed consent
- Contraindications to positive airway pressure:
- Severe bullous lung disease
- Dehydration
Show all 14Show fewer
- Cerebrospinal fluid leak
- Acute sinusitis or otitis media
- Epistaxis (severe nose bleeds) causing a risk of pulmonary aspiration
- Conditions predisposing to a risk of vomiting into mask
- Impaired ability to clear secretions
- Hypotension (defined as systolic BP < 100mmHg) or significant intravascular volume depletion
- Pneumothorax or pneumomediastinum
- Recent cranial trauma or surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptive Servo Ventilation (ASV) in the Management of Acute Decompensated Heart Failure (ADHF)
Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. SDB is however, treatable with the use of non invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The aim of the study is to observe and investigate the potential role of ASV in the management of heart failure.
Patients that agree to participate in this study will be requested to use an ASV ventilator device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is approximately the size of a large shoe box, which can be placed at the side of the bed, with tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows positive air pressure as determined by the device itself as it constantly monitors the patients breathing throughout the night. During this study, the patients breathing patterns will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a SleepMinder will sit on the patients bedside locker as another form of monitoring of their sleep patterns. Study staff will monitor the patient and give them frequent support, and they will also be asked questions regarding their experiences with this equipment and any symptoms they may have over this time. They will be followed up regarding this study at the same time as their follow-up requirements for their heart failure. This study will be conducted in total over 3 months.
Read the detailed description
Sleep disordered breathing (SDB) is common in patients with heart failure (HF) and is an independent predictor of morbidity and mortality. Adaptive servo-ventilation (ASV) is reported as the most effective treatment for SDB in HF and has been shown to improve cardiac function in patients with HF coexistent with SDB. ASV may also be an effective therapeutic option for patients with HF regardless of presence or severity of SDB.
The aim of the study is to investigate the potential role for ASV in improving the management of ADHF in the acute hospital phase and reducing complications in the vulnerable post discharge period. This is an observational study of forty patients admitted to hospital with ADHF.
In this clinical investigation, the ApneaLinkTM Plus device will measure patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The research participant will be connected to the device during their inpatient hospitalisation as soon as they are stabilised off oxygen. These recordings will aid the diagnosis of SDB for further clinical investigation.
The S9 Autoset CS-A system will be evaluated to determine whether ASV has beneficial effects on the cardiac function of patients with ADHF. During an in-patient run-in phase, the patients tolerability to ASV therapy will be assessed and if tolerated well, the patient will continue with this therapy following discharge for 45 days.
The SleepMinder sensor device will monitor the sleep and breathing patterns of the participants as they sleep, and in doing so, sleep apnoeas will be detected. Each patient will monitor their weight daily using a Precision Personal Health Scales for 90 days. Finally, a questionnaire will be completed by the patient which allows them to self-report their HF symptoms.
- Being tested
- S9-Autoset CS-A
- Keywords
- Adaptive Servo Ventilation, Acute decompensated heart failure, SleepMinder, ApneaLink Plus, Sleep disordered breathing, Natriuretic peptide
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S9-Autoset CS-ADevice
The S9-Autoset CS-A is an adaptive servo-ventilation (ASV) machine. It adjusts the level of inspiratory support automatically in response to the patient's respiratory effort. Inspiratory support is increased in the presence of hypoventilation and decreased in the presence of hyperventilation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of inpatient HF hospitalisation
Admission to ready-for-discharge in days
Measured: Patients are followed during the inpatient admission, currently an average of 14 days
Time to clinical stability (days)
Measured: Patients are followed during the inpatient admission and an approximate time to clinical stability is determined, currently less than an average of 14 days
Secondary outcomes (11)
Time to event using a combined morbidity index
Time to event using a combined morbidity index including re-hospitalisation (all-cause, cardiac, HF), outpatient attendance with intravenous diuretics, outpatient attendance with symptomatic deteriorations requiring adjustment of oral diuretic, home/patient adjustment of oral diuretic treatment without patient outpatient clinic attendance.
Measured: From baseline to study end, an average of approximately 12 months
Natriuretic peptide (NTproBNP) levels
Measured: Baseline, 45 days and 90 days
B-Type Natriuretic peptide (BNP) levels
Measured: Baseline, 45 days and 90 days
Ejection fraction
Measured: Baseline, 45 days and 90 days
Creatinine clearance
Measured: Baseline, 45 days and 90 days
Markers of renal damage
Kidney injury molecule-1(KIM-1)
Measured: Baseline, 45 days and 90 days
Markers of renal damage
Neutrophil gelatinase-associated lipocalin (NGAL)
Measured: Baseline, 45 days and 90 days
Markers of matrix turnover
Matrix metalloproteinase (MMP)-2 and -9
Measured: Baseline, 45 days and 90 days
Markers of inflammation
hsCRP
Measured: Baseline, 45 days and 90 days
Comparative Sleep Disordered Breathing
Measured by the ApneaLinkTM Plus
Measured: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Comparative Sleep Disordered Breathing
Measured by SleepMinder
Measured: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2013
- Primary completionMay 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Mark Ledwidge, St Vincent's University Hospital, Ireland
- Investigators
- Kenneth M McDonald, MD, Principal investigator, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440971
- Sponsor's protocol ID
- HFU-CM-001
- Status last verified
- Jul 2018
- First submitted
- 23 Dec 2013
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Servo Ventilation (ASV) in the Management of Acute Decompensated Heart Failure (ADHF)
- ClinicalTrials.gov ID
- NCT02440971
- Acronym / sponsor ID
- HFU-CM-001
- Keywords
- Adaptive Servo Ventilation, Acute decompensated heart failure, SleepMinder, ApneaLink Plus, Sleep disordered breathing, Natriuretic peptide
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- May 2013
- Primary completion
- May 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 12 May 2015 (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.
Up to 60% of patients with heart failure show abnormal patterns of breathing (sleep disordered breathing (SDB)) at night which can increase the risk of recurrent admissions and have important prognostic implications. SDB is however, treatable with the use of non invasive breathing support devices such as the adaptive servo ventilation (ASV) device. The aim of the study is to observe and investigate the potential role of ASV in the management of heart failure.
Patients that agree to participate in this study will be requested to use an ASV ventilator device (called the AutoSet CS-A) to help their SDB for approximately 6 weeks. The device is approximately the size of a large shoe box, which can be placed at the side of the bed, with tubing and a mask. At night, the mask is placed over the nose and/or mouth and it blows positive air pressure as determined by the device itself as it constantly monitors the patients breathing throughout the night. During this study, the patients breathing patterns will be monitored non-invasively using the ApneaLink device. A non-contact device knows as a SleepMinder will sit on the patients bedside locker as another form of monitoring of their sleep patterns. Study staff will monitor the patient and give them frequent support, and they will also be asked questions regarding their experiences with this equipment and any symptoms they may have over this time. They will be followed up regarding this study at the same time as their follow-up requirements for their heart failure. This study will be conducted in total over 3 months.
Detailed description
Sleep disordered breathing (SDB) is common in patients with heart failure (HF) and is an independent predictor of morbidity and mortality. Adaptive servo-ventilation (ASV) is reported as the most effective treatment for SDB in HF and has been shown to improve cardiac function in patients with HF coexistent with SDB. ASV may also be an effective therapeutic option for patients with HF regardless of presence or severity of SDB.
The aim of the study is to investigate the potential role for ASV in improving the management of ADHF in the acute hospital phase and reducing complications in the vulnerable post discharge period. This is an observational study of forty patients admitted to hospital with ADHF.
In this clinical investigation, the ApneaLinkTM Plus device will measure patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The research participant will be connected to the device during their inpatient hospitalisation as soon as they are stabilised off oxygen. These recordings will aid the diagnosis of SDB for further clinical investigation.
The S9 Autoset CS-A system will be evaluated to determine whether ASV has beneficial effects on the cardiac function of patients with ADHF. During an in-patient run-in phase, the patients tolerability to ASV therapy will be assessed and if tolerated well, the patient will continue with this therapy following discharge for 45 days.
The SleepMinder sensor device will monitor the sleep and breathing patterns of the participants as they sleep, and in doing so, sleep apnoeas will be detected. Each patient will monitor their weight daily using a Precision Personal Health Scales for 90 days. Finally, a questionnaire will be completed by the patient which allows them to self-report their HF symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted into hospital for acute management of ADHF are eligible to participate in this study (providing inclusion/exclusion criteria are met)
Key inclusion criteria (4 listed)
- Admitted to the hospital with a primary diagnosis of ADHF
- Stable off oxygen for 24 hours
- Informed consent
- Age ≥ 18 years
Key exclusion criteria (14 listed)
- Age < 18 years
- Pregnant women, breastfeeding mothers
- Anyone not capable of giving informed consent
- Contraindications to positive airway pressure:
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 |
|---|---|---|
| S9-Autoset CS-AThe S9-Autoset CS-A is an adaptive servo-ventilation (ASV) machine. It adjusts the level of inspiratory support automatically in response to the patient's respiratory effort. Inspiratory support is increased in the presence of hypoventilation and decreased in the presence of hyperventilation. | Device | – |
Primary outcome
Length of inpatient HF hospitalisation
Time frame: Patients are followed during the inpatient admission, currently an average of 14 days
Admission to ready-for-discharge in days
Time to clinical stability (days)
Time frame: Patients are followed during the inpatient admission and an approximate time to clinical stability is determined, currently less than an average of 14 days
11 secondary outcomes
Time to event using a combined morbidity index
Time frame: From baseline to study end, an average of approximately 12 months
Natriuretic peptide (NTproBNP) levels
Time frame: Baseline, 45 days and 90 days
B-Type Natriuretic peptide (BNP) levels
Time frame: Baseline, 45 days and 90 days
Ejection fraction
Time frame: Baseline, 45 days and 90 days
Creatinine clearance
Time frame: Baseline, 45 days and 90 days
Markers of renal damage
Time frame: Baseline, 45 days and 90 days
Markers of renal damage
Time frame: Baseline, 45 days and 90 days
Markers of matrix turnover
Time frame: Baseline, 45 days and 90 days
Markers of inflammation
Time frame: Baseline, 45 days and 90 days
Comparative Sleep Disordered Breathing
Time frame: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Comparative Sleep Disordered Breathing
Time frame: Baseline, 45 days, 90 days and study end, an average of approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
Kenneth M McDonald, MD principal investigator
St Vincent's University Hospital, Ireland
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 Acute Decompensated Heart Failure and Sleep Disordered Breathing, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
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 4 inclusion and 14 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: paused, as of the sponsor's last update on 26 Jul 2018. 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 Ireland. 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?
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?
Length of inpatient HF hospitalisation (time frame: Patients are followed during the inpatient admission, currently an average of 14 days). The study lists 2 primary outcomes in all. 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 26 Jul 2018.