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Cardiac Resynchronisation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213537
First Posted: October 4, 2010
Last Update Posted: October 22, 2015
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.
Information provided by (Responsible Party):
Rebecca Lucas, Imperial College London
  Purpose
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.

Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:


Further study details as provided by Rebecca Lucas, Imperial College London:

Primary Outcome Measures:
  • 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.


Enrollment: 182
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients undergoing clinically indicated CRT implantation

Patients may be included in the study if they fulfil the following;

  1. Age ≥18 years old
  2. 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
  3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks
  4. No changes in medications for heart failure in preceding 4 weeks
  5. Able to read and understand patient information sheet and give informed consent

Patients must be excluded from the study if they fulfil they the following;

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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Chronic Heart Failure who fulfil the current national guidelines for CRT insertion (see inclusion criteria)
Criteria

Inclusion Criteria:

  1. Age ≥18 years old
  2. 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
  3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks
  4. No changes in medications for heart failure in preceding 4 weeks
  5. Able to read and understand patient information sheet and give informed consent

Exclusion Criteria:

  1. On positive pressure treatment for known sleep disordered breathing at the time of inclusion
  2. Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
  3. Pregnancy
  Contacts and Locations
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): NCT01213537


Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
  More Information

Additional Information:
Responsible Party: Rebecca Lucas, Mrs, Imperial College London
ClinicalTrials.gov Identifier: NCT01213537     History of Changes
Other Study ID Numbers: 10/H0706/5
First Submitted: October 1, 2010
First Posted: October 4, 2010
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Rebecca Lucas, Imperial College London:
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases