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

August 12, 2014 updated by: Barts & The London NHS Trust

Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts and The London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004844BLT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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