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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Barts & The London NHS Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT01100918
First received: April 8, 2010
Last updated: January 31, 2013
Last verified: March 2011
  Purpose

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 Intervention Phase
Heart Failure
Device: BiV ICD
Device: ICD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Utility of Tissue Doppler Echocardiography for Selecting Patients for Cardiac Resynchronisation Therapy in Heart Failure

Resource links provided by NLM:


Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • Cardiopulmonary Exercise Testing - changes in Peak VO2 from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in New York Heart Association (NYHA) class from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in Quality-of-Life score from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Echocardiography - changes in left ventricular (LV) volume and dimensions, calculated ejection fractions and in severity of MR [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: February 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT01100918     History of Changes
Other Study ID Numbers: 004844BLT
Study First Received: April 8, 2010
Last Updated: January 31, 2013
Health Authority: UK: National Health Service

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

ClinicalTrials.gov processed this record on April 20, 2014