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The Effect of CRT on the Hypercapnic Ventilatory Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203383
Recruitment Status : Suspended (Pending further equipment and staff)
First Posted : July 29, 2014
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief 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 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.

Condition or disease Intervention/treatment
Sleep Disordered Breathing Heart Failure Device: CRT Implantation

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sleep Disordered Breathing in Patients With Implanted Cardiac Devices: Assessment of the Change in Sensitivity to Carbon Dioxide With Cardiac Resynchronization Therapy.
Study Start Date : June 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Pts with CSA for CRT implantation
Patients with heart failure (EF<40%) and moderate to severe CSA (>15 events per hour, >50% Central)
Device: CRT Implantation
Implantation of a biventricular pacemaker or defibrillator.
Other Names:
  • INVIVE
  • INCEPTA
  • AUTOGEN

No Sleep Apnoea for CRT implantation
Heart failure (EF < 40%) but no significant sleep apnoea (<5 events per hour).
Device: CRT Implantation
Implantation of a biventricular pacemaker or defibrillator.
Other Names:
  • INVIVE
  • INCEPTA
  • AUTOGEN




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: 6 weeks and 6 months ]
  2. Change in resting PaCO2 [ Time Frame: 6 weeks and 6 months ]
  3. Change in left ventricular ejection fraction [ Time Frame: 6 weeks and 6 months ]
  4. Change in plasma B-Type Natriuretic Peptide level [ Time Frame: 6 weeks and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients on Non-Invasive Ventilation
  • Predominant OSA
  • Unable to consent or attend for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203383


Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom, SW6 6NP
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Boston Scientific Corporation
Investigators
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Principal Investigator: Ali Vazir, PhD Imperial College. Royal Brompton Hospital
Study Chair: Martin Cowie, MD Imperial College London
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02203383    
Other Study ID Numbers: 14/LO/0078
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cardiac Resynchronization Therapy
Central Sleep Apnoea
Sleep Disordered Breathing
Heart Failure
Hypercapnic Ventilatory Response
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases