Sleep Disordered BreathingNCT02203383
The Effect of CRT on the Hypercapnic Ventilatory Response
An observational study of Sleep Disordered Breathing and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Heart Failure
- What is being tested?
- CRT Implantation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Oct 2017
- 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 with heart failure with reduced ejection fraction (<40% on echocardiography) due to undergo implantation of a biventricular pacemaker, with either no significant sleep disordered breathing or moderate to severe CSA.
Who may be able to join
- Heart failure with reduced ejection fraction (<40%)
- Either no significant sleep disordered breathing or moderate to severe CSA
- Able to consent to the study
- Ambulatory
- Aged 18-100 years
Who cannot join
- Patients on Non-Invasive Ventilation
- Predominant OSA
- Unable to consent or attend for the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
London, SW6 6NP
About this study
Official title: Sleep Disordered Breathing in Patients With Implanted Cardiac Devices: Assessment of the Change in Sensitivity to Carbon Dioxide With Cardiac Resynchronization Therapy.
Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.
Read the detailed description
Sleep disordered Breathing is common in heart failure, affecting around half of patients. This may be Obstructive Sleep Apnoea due to loss of pharyngeal muscle tone (OSA, associated with obesity and snoring and predisposing to hypertension, heart attack and stroke) or Central Sleep Apnoea (CSA). CSA is particularly prevalent in severe heart failure and associated with an adverse prognosis. The mechanism involves reflex hyperventilation due to pulmonary oedema, exaggerated chemosensor response to hypercapnoea associated with increased sympathetic nervous system activation and a prolonged circulation time.
It is known that CRT improved CSA in 'responders' but the mechanism is unknown. We hypothesis that CRT normalizes the respiratory response to carbon dioxide (the hypercapnic ventilatory response - HCVR).
We will screen patients undergoing CRT with an Embletta sleep study to identify a group with moderate to severe CSA and a group with no sleep apnoea (controls). Patients will undergo assessment of the hypercapnic ventilatory response with a Read Re-Breathe test prior to device implantation and 6 weeks and 6 months afterwards. The gradient of minute ventilation vs PaCO2 will be compared.
- Conditions
- Sleep Disordered Breathing, Heart Failure
- Being tested
- CRT Implantation
- Keywords
- Cardiac Resynchronization Therapy, Central Sleep Apnoea, Sleep Disordered Breathing, Heart Failure, Hypercapnic Ventilatory Response
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT ImplantationDevice
Also called INVIVE, INCEPTA, AUTOGEN
Implantation of a biventricular pacemaker or defibrillator.
| Study group | Role | What they receive |
|---|---|---|
| Pts with CSA for CRT implantation | Patients with heart failure (EF<40%) and moderate to severe CSA (>15 events per hour, >50% Central) Receives: Device: CRT Implantation | |
| No Sleep Apnoea for CRT implantation | Heart failure (EF < 40%) but no significant sleep apnoea (<5 events per hour). Receives: Device: CRT Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response).
Measured: 6 weeks and 6 months
Secondary outcomes (4)
6 minute walk distance
Measured: 6 weeks and 6 months
Change in resting PaCO2
Measured: 6 weeks and 6 months
Change in left ventricular ejection fraction
Measured: 6 weeks and 6 months
Change in plasma B-Type Natriuretic Peptide level
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Pending further equipment and staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Ali Vazir, PhD, Principal investigator, Imperial College. Royal Brompton HospitalMartin Cowie, MD, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203383
- Sponsor's protocol ID
- 14/LO/0078
- Status last verified
- Nov 2016
- First submitted
- 28 Jul 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Patients With Implanted Cardiac Devices: Assessment of the Change in Sensitivity to Carbon Dioxide With Cardiac Resynchronization Therapy.
- ClinicalTrials.gov ID
- NCT02203383
- Acronym / sponsor ID
- 14/LO/0078
- Conditions
- Sleep Disordered Breathing, Heart Failure
- Keywords
- Cardiac Resynchronization Therapy, Central Sleep Apnoea, Sleep Disordered Breathing, Heart Failure, Hypercapnic Ventilatory Response
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Pending further equipment and staff
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jun 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 29 Jul 2014 (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 Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.
Detailed description
Sleep disordered Breathing is common in heart failure, affecting around half of patients. This may be Obstructive Sleep Apnoea due to loss of pharyngeal muscle tone (OSA, associated with obesity and snoring and predisposing to hypertension, heart attack and stroke) or Central Sleep Apnoea (CSA). CSA is particularly prevalent in severe heart failure and associated with an adverse prognosis. The mechanism involves reflex hyperventilation due to pulmonary oedema, exaggerated chemosensor response to hypercapnoea associated with increased sympathetic nervous system activation and a prolonged circulation time.
It is known that CRT improved CSA in 'responders' but the mechanism is unknown. We hypothesis that CRT normalizes the respiratory response to carbon dioxide (the hypercapnic ventilatory response - HCVR).
We will screen patients undergoing CRT with an Embletta sleep study to identify a group with moderate to severe CSA and a group with no sleep apnoea (controls). Patients will undergo assessment of the hypercapnic ventilatory response with a Read Re-Breathe test prior to device implantation and 6 weeks and 6 months afterwards. The gradient of minute ventilation vs PaCO2 will be compared.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pts with CSA for CRT implantation | – | Device: CRT ImplantationPatients with heart failure (EF<40%) and moderate to severe CSA (>15 events per hour, >50% Central) |
| No Sleep Apnoea for CRT implantation | – | Device: CRT ImplantationHeart failure (EF < 40%) but no significant sleep apnoea (<5 events per hour). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure with reduced ejection fraction (<40% on echocardiography) due to undergo implantation of a biventricular pacemaker, with either no significant sleep disordered breathing or moderate to severe CSA.
Key inclusion criteria (5 listed)
- Heart failure with reduced ejection fraction (<40%)
- Either no significant sleep disordered breathing or moderate to severe CSA
- Able to consent to the study
- Ambulatory
- Aged 18-100 years
Key exclusion criteria (3 listed)
- Patients on Non-Invasive Ventilation
- Predominant OSA
- Unable to consent or attend for the study
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 |
|---|---|---|
| CRT ImplantationAlso: INVIVE, INCEPTA, AUTOGENImplantation of a biventricular pacemaker or defibrillator. | Device | No Sleep Apnoea for CRT implantation, Pts with CSA for CRT implantation |
Primary outcome
The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response).
Time frame: 6 weeks and 6 months
4 secondary outcomes
6 minute walk distance
Time frame: 6 weeks and 6 months
Change in resting PaCO2
Time frame: 6 weeks and 6 months
Change in left ventricular ejection fraction
Time frame: 6 weeks and 6 months
Change in plasma B-Type Natriuretic Peptide level
Time frame: 6 weeks and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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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.
Ali Vazir, PhD principal investigator
Imperial College. Royal Brompton Hospital
Martin Cowie, MD study chair
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 Sleep Disordered Breathing and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust 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 5 inclusion and 3 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 9 Nov 2016. 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?
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?
The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response). (time frame: 6 weeks and 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 9 Nov 2016; AzTrials last refreshed its copy on 5 Nov 2026.