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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure
Study Start Date : February 2007
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1: Dyssynchrony positive Device: BiV ICD
Biventricular ICD
Active Comparator: 2a: Dyssynchrony negative Device: BiV ICD
Biventricular ICD
Active Comparator: 2b: Dyssynchrony negative Device: ICD
Implantable Defibrillator


Outcome Measures

Primary Outcome Measures :
  1. Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change in New York Heart Association (NYHA) class from baseline to 6 months [ Time Frame: 6 months ]
  2. Change in Quality-of-Life score from baseline to 6 months [ Time Frame: 6 months ]
  3. Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have an indication for ICD therapy
  2. Heart failure of any aetiology with evidence of left ventricular (LV) systolic dysfunction with LV ejection fraction < 35% and LV cavity dilatation (end diastolic dimension > 55 mm)
  3. NYHA Class III/IV symptoms of heart failure despite optimal medical therapy
  4. QRS duration ≥120ms

Exclusion Criteria:

  1. Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease
  2. Requirement for ventricular pacing due to atrioventricular block.
  3. Limited life expectancy (< 6 months)
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): NCT01100918


Locations
United Kingdom
Barts and the London NHS Trust
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Richard Schilling, MD, FRCP Barts and the London NHS Trust, Queen Mary University of London
More Information

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01100918     History of Changes
Other Study ID Numbers: 004844BLT
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by Barts & The London NHS Trust:
Cardiac resynchronisation therapy
Tissue Doppler Imaging
Dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases