Cardiac Resynchronisation Study

NCT01213537 | Completed

• 1 other identifier: 10/H0706/5
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart failure

Outcome Measures

Primary Outcomes (1)

• Change in chemosensitivity before and after CRT implantation

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

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Chronic Heart Failure who fulfil the current national guidelines for CRT insertion (see inclusion criteria)

You may qualify if:

• 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

You may not qualify if:

• Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
• Pregnancy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Royal Brompton Hospital

London, London, SW3 6NP, United Kingdom

Location

Related Links

• National Institute of Clinical Excellence; technology appraisal about CRT devices

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

GB (1)