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Completed

NCT Number: NCT01213537

Cardiac Resynchronisation Study

This study aims to investigate the effect of a pacemaker device used in heart failure patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the investigators aim to investigate if the CRT pacemaker has an effect on breathing stability in these patients and particularly breathing stability at night. Our theory is that the CRT pacemaker may improve the stability of breathing in patients with heart failure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

About this study

AIM To investigate the effect of Cardiac Resynchronisation Therapy (CRT) on chemosensitivity in patients with Chronic Heart Failure with and without Sleep Disordered Breathing (SDB).

OBJECTIVE To conduct a physiological observational study to measure hypercapnic ventilatory responses in a group of CHF patients before and 3 months after implantation of clinically indicated CRT devices. Additionally to conduct nocturnal polysomnography to establish if any change in chemosensitivity is related to the presence of SDB at baseline and, where present, any change in SDB after implantation.

HYPOTHESIS Primary hypothesis: CRT implantation will be associated with a reduction in the hypercapnic ventilatory response from baseline to 3 months post implantation.

Additional hypothesis: This reduction in hypercapnic ventilatory response after CRT implantation will be greatest in those CHF patients with SDB at baseline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old
  • Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF <35%, functional impairment as defined by an NYHA class of III-IV
  • Clinically stable with no unplanned admission to hospital for preceding 4 weeks
  • No changes in medications for heart failure in preceding 4 weeks
  • Able to read and understand patient information sheet and give informed consent

Exclusion criteria

  • On positive pressure treatment for known sleep disordered breathing at the time of inclusion
  • Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Change in chemosensitivity before and after CRT implantation

    Time frame: 3 months

    We will look primarily at the effect of CRT implantation on chemosensitity which we will measure using the ventilatory sensitivity to carbon dioxide.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

A Study of the Effect of Cardiac Resynchronisation Therapy (CRT) on Chemosensitivity in Patients With Chronic Heart Failure With and Without Sleep Disordered Breathing.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Oct 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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