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OpenTrials
Completed

NCT Number: NCT01100918

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

BiV ICD

Device

Biventricular ICD

ICD

Device

Implantable Defibrillator

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

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

Acronym: TIBI-HF

Important dates

Study start
2007
Study completion
2010
First posted
Apr 9, 2010
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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