Cardiac Resynchronisation Study
Recruitment status was Recruiting
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.
|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.|
- Change in chemosensitivity before and after CRT implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]We will look primarily at the effect of CRT implantation on chemosensitity which we will measure using the ventilatory sensitivity to carbon dioxide.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||October 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Patients undergoing clinically indicated CRT implantation
Patients may be included in the study if they fulfil the following;
Patients must be excluded from the study if they fulfil they the following;
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213537
|Contact: Angela Atalla, MBChB, MRCP, DTM&Hfirstname.lastname@example.org|
|Contact: Angela Atallaemail@example.com|
|Royal Brompton Hospital||Recruiting|
|London, United Kingdom, SW3 6NP|
|Sub-Investigator: Angela Atalla, MBChB, MRCP, DTM&H|
|Principal Investigator: Martin Cowie, MD|