Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy (TIBI-HF)
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|ClinicalTrials.gov Identifier: NCT01100918|
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : August 13, 2014
Currently the main selection tool for Cardiac Resynchronisation Therapy (CRT) is the QRS duration on the surface echocardiography (ECG) which has been shown to be a poor predictor of response. We sought to evaluate the use of tissue Doppler (TDI) assessment of dyssynchrony in prediction of response to CRT.
The hypothesis is that the presence of mechanical dyssynchrony (measured using TDI echocardiography) successfully identifies heart failure patients who will respond to CRT. Conversely, the absence of mechanical dyssynchrony is associated with a low/no response to CRT.
This is a three arm study. Group 1 comprises patients with dyssynchrony on TDI who are implanted with a biventricular ICD whereas Group 2 patients comprise patients who have no dyssynchrony. Group 2 patients are randomised 1:1 to either receive a biventricular ICD (2a) or an ICD (2b). All patients undergo a NYHA class assessment, a cardiopulmonary exercise test, and an echocardiogram at baseline and at 6 months follow up. Baseline and 6 months findings will be compared in all three groups.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: BiV ICD Device: ICD||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure|
|Study Start Date :||February 2007|
|Actual Study Completion Date :||December 2010|
|Active Comparator: 1: Dyssynchrony positive||
Device: BiV ICD
|Active Comparator: 2a: Dyssynchrony negative||
Device: BiV ICD
|Active Comparator: 2b: Dyssynchrony negative||
- Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months [ Time Frame: 6 months ]
- Change in New York Heart Association (NYHA) class from baseline to 6 months [ Time Frame: 6 months ]
- Change in Quality-of-Life score from baseline to 6 months [ Time Frame: 6 months ]
- Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR [ Time Frame: 6 months ]
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): NCT01100918
|Barts and the London NHS Trust|
|London, United Kingdom, EC1A 7BE|
|Principal Investigator:||Richard Schilling, MD, FRCP||Barts and the London NHS Trust, Queen Mary University of London|