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Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy (TIBI-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
BiV ICD
ICD
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resynchronisation therapy, Tissue Doppler Imaging, Dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Barts and the London NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1: Dyssynchrony positive

2a: Dyssynchrony negative

2b: Dyssynchrony negative

Arm Description

Outcomes

Primary Outcome Measures

Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months

Secondary Outcome Measures

Change in New York Heart Association (NYHA) class from baseline to 6 months
Change in Quality-of-Life score from baseline to 6 months
Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR

Full Information

First Posted
April 8, 2010
Last Updated
August 12, 2014
Sponsor
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01100918
Brief Title
Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy
Acronym
TIBI-HF
Official Title
Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac resynchronisation therapy, Tissue Doppler Imaging, Dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Dyssynchrony positive
Arm Type
Active Comparator
Arm Title
2a: Dyssynchrony negative
Arm Type
Active Comparator
Arm Title
2b: Dyssynchrony negative
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
BiV ICD
Intervention Description
Biventricular ICD
Intervention Type
Device
Intervention Name(s)
ICD
Intervention Description
Implantable Defibrillator
Primary Outcome Measure Information:
Title
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in New York Heart Association (NYHA) class from baseline to 6 months
Time Frame
6 months
Title
Change in Quality-of-Life score from baseline to 6 months
Time Frame
6 months
Title
Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have an indication for ICD therapy 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) NYHA Class III/IV symptoms of heart failure despite optimal medical therapy QRS duration ≥120ms Exclusion Criteria: Reversible cause of heart failure such as ongoing ischaemia amenable to revascularisation or treatable valvular disease Requirement for ventricular pacing due to atrioventricular block. Limited life expectancy (< 6 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Schilling, MD, FRCP
Organizational Affiliation
Barts and the London NHS Trust, Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts and the London NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom

12. IPD Sharing Statement

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Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy

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