Heart FailureNCT00976417
Mechanisms of Action of Adaptive Servoventilation
An observational study of Heart Failure and Sleep Apnea Syndromes, run by ResMed at 1 site in United Kingdom.
Trial summary
It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Sleep Apnea Syndromes
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Oct 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients already recruited to the SERVE-HF study.
Who may be able to join
- Over 18 years of age
- Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 12 months
- Left ventricular ejection fraction (LVEF) <40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
- Diagnosis of sleep disordered breathing SDB (apnoea-hypopnoea-index (AHI >15/h) with ≥ 50% central events and a central AHI ≥ 10/h)
- Clinically stable with no change in medication and no hospitalisation in preceding month
- Optimised medical treatment according to the applicable guidelines
- Able to provide informed consent
Who cannot join
- Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1) <50%
- Oxygen saturation at rest during the day ≤ 90% at inclusion
- Current use of Positive Airway Pressure (PAP) therapy
- Life expectancy < 1 year for diseases unrelated to chronic heart failure
- Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
- Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
Show all 11Show fewer
- Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
- Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
- Acute myocarditis/pericarditis within 6 months prior to randomisation
- Untreated or therapy refractory Restless legs Syndrome (RLS)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton Hospital and Imperial College
London
About this study
Official title: Mechanisms of Action of Adaptive Servoventilation: Ventilatory Control in Heart Failure Patients With Central Sleep Apnoea
It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB. The SERVE-HF study aims to look at the effect of a breathing support machine, or ventilator called Adaptive Servo-ventilation (ASV) on mortality in heart failure patients with central sleep apnoea. In this related sub-study the investigators want to look at how the ASV machine has its effect. The investigators will be carrying out tests in the laboratory to measure various aspects of the way that breathing is controlled to measure the effect that ASV has on patients.
In addition measurements looking at activity levels will be made using an actiwatch device worn by patients for 14 consecutive days and nights.
Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline and 3 months) to allow comparison of data between patients and controls.
Read the detailed description
As part of a wider study we are interested in how patients with a failing heart breathe during sleep. It is known that patients with heart failure and central sleep apnoea (a form of breathing difficulty during sleep) have a poorer prognosis. It is likely that this is because this condition places an extra strain on the heart. We want to investigate whether or not treating these breathing problems is of benefit to this group of patients. The proposed study will investigate why a significant proportion of patients with heart failure have central sleep apnoea and how they respond to treatment. We will do this by measuring some of the factors which contribute to how they breathe:
(i) How the brain changes the breathing rate and depth in response to a change in carbon dioxide levels (Chemosensitivity); (ii) How the blood vessels in the brain change in response to a change in carbon dioxide levels (Cerebral Vascular Reactivity); (iii) An overall measure of breathing control called "Loop Gain" (this protocol will only be undertaken in a subgroup of patients who will give specific consent).
These measurements will be carried out in the laboratory in patients taking part in SERVE-HF; a multicentre randomised controlled study of adaptive servoventilation (ASV). ASV is a form of non-invasive ventilation (delivered by a mask worn on the face) shown in previous smaller studies to adequately suppress sleep disordered breathing. The proposed study will allow us to take measurements from patients assigned to both the treatment and control groups; and compare measurements made in both groups at the start of treatment and at three months.
In addition measurements looking at activity levels will be made using an actiwatch device worn by patients for 14 consecutive days and nights. Previously it has been demonstrated that heart failure patients with sleep disordered breathing have lower levels of daytime activity when compared to heart failure patients without sleep disordered breathing. We will investigate the effect of ASV on activity measurements on this patients with sleep disordered breathing.
Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline and 3 months) to allow comparison of data between patients and controls.
- Conditions
- Heart Failure, Sleep Apnea Syndromes
- 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 |
|---|---|---|
| 1. Patients in the control group | Not described | |
| 2. Patients in the intervention group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionOct 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.
- More trials run by ResMedThe 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Imperial College London
- Responsible party
- Sponsor
- Investigators
- Mary Morrell, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976417
- Sponsor's protocol ID
- 09/H0708/35
- Status last verified
- Nov 2011
- First submitted
- 11 Sep 2009
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action of Adaptive Servoventilation: Ventilatory Control in Heart Failure Patients With Central Sleep Apnoea
- ClinicalTrials.gov ID
- NCT00976417
- Acronym / sponsor ID
- 09/H0708/35
- Conditions
- Heart Failure, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, Imperial College London
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Sep 2009 (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.
It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB. The SERVE-HF study aims to look at the effect of a breathing support machine, or ventilator called Adaptive Servo-ventilation (ASV) on mortality in heart failure patients with central sleep apnoea. In this related sub-study the investigators want to look at how the ASV machine has its effect. The investigators will be carrying out tests in the laboratory to measure various aspects of the way that breathing is controlled to measure the effect that ASV has on patients.
In addition measurements looking at activity levels will be made using an actiwatch device worn by patients for 14 consecutive days and nights.
Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline and 3 months) to allow comparison of data between patients and controls.
Detailed description
As part of a wider study we are interested in how patients with a failing heart breathe during sleep. It is known that patients with heart failure and central sleep apnoea (a form of breathing difficulty during sleep) have a poorer prognosis. It is likely that this is because this condition places an extra strain on the heart. We want to investigate whether or not treating these breathing problems is of benefit to this group of patients. The proposed study will investigate why a significant proportion of patients with heart failure have central sleep apnoea and how they respond to treatment. We will do this by measuring some of the factors which contribute to how they breathe:
(i) How the brain changes the breathing rate and depth in response to a change in carbon dioxide levels (Chemosensitivity); (ii) How the blood vessels in the brain change in response to a change in carbon dioxide levels (Cerebral Vascular Reactivity); (iii) An overall measure of breathing control called "Loop Gain" (this protocol will only be undertaken in a subgroup of patients who will give specific consent).
These measurements will be carried out in the laboratory in patients taking part in SERVE-HF; a multicentre randomised controlled study of adaptive servoventilation (ASV). ASV is a form of non-invasive ventilation (delivered by a mask worn on the face) shown in previous smaller studies to adequately suppress sleep disordered breathing. The proposed study will allow us to take measurements from patients assigned to both the treatment and control groups; and compare measurements made in both groups at the start of treatment and at three months.
In addition measurements looking at activity levels will be made using an actiwatch device worn by patients for 14 consecutive days and nights. Previously it has been demonstrated that heart failure patients with sleep disordered breathing have lower levels of daytime activity when compared to heart failure patients without sleep disordered breathing. We will investigate the effect of ASV on activity measurements on this patients with sleep disordered breathing.
Healthy controls will be recruited to all parts of this protocol (ie measurements at baseline and 3 months) to allow comparison of data between patients and controls.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Patients in the control group | – | – |
| 2. Patients in the intervention group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already recruited to the SERVE-HF study.
Key inclusion criteria (7 listed)
- Over 18 years of age
- Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 12 months
- Left ventricular ejection fraction (LVEF) <40% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
- Diagnosis of sleep disordered breathing SDB (apnoea-hypopnoea-index (AHI >15/h) with ≥ 50% central events and a central AHI ≥ 10/h)
- Clinically stable with no change in medication and no hospitalisation in preceding month
Key exclusion criteria (11 listed)
- Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1) <50%
- Oxygen saturation at rest during the day ≤ 90% at inclusion
- Current use of Positive Airway Pressure (PAP) therapy
- Life expectancy < 1 year for diseases unrelated to chronic heart failure
- Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
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
Not reported in the source record.
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 7 Dec 2011.
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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.
Mary Morrell, PhD principal investigator
Imperial College London
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 Syndromes, run by ResMed at 1 site in United Kingdom.
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 11 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 7 Dec 2011. 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 United Kingdom. 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.
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 Dec 2011.