Cardiac Resynchronisation Study
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|ClinicalTrials.gov Identifier: NCT01213537|
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : October 22, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||182 participants|
|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.|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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;
- 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.
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
|Royal Brompton Hospital|
|London, United Kingdom, SW3 6NP|