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The Effect of CRT on the Hypercapnic Ventilatory Response

NCT ID: NCT02203383

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Sleep Disordered Breathing Heart Failure

Keywords

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Cardiac Resynchronization Therapy Central Sleep Apnoea Sleep Disordered Breathing Heart Failure Hypercapnic Ventilatory Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pts with CSA for CRT implantation

Patients with heart failure (EF\<40%) and moderate to severe CSA (\>15 events per hour, \>50% Central)

CRT Implantation

Intervention Type DEVICE

Implantation of a biventricular pacemaker or defibrillator.

No Sleep Apnoea for CRT implantation

Heart failure (EF \< 40%) but no significant sleep apnoea (\<5 events per hour).

CRT Implantation

Intervention Type DEVICE

Implantation of a biventricular pacemaker or defibrillator.

Interventions

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CRT Implantation

Implantation of a biventricular pacemaker or defibrillator.

Intervention Type DEVICE

Other Intervention Names

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INVIVE INCEPTA AUTOGEN

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Vazir, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College. Royal Brompton Hospital

Martin Cowie, MD

Role: STUDY_CHAIR

Imperial College London

Locations

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Royal Brompton and Harefield NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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14/LO/0078

Identifier Type: -

Identifier Source: org_study_id