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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100918

Acronym

TIBI-HF

Enrollment

Registered

2010-04-09

Start date

2007-02-28

Completion date

2010-12-31

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac resynchronisation therapy, Tissue Doppler Imaging, Dyssynchrony

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.

Interventions

DEVICEBiV ICD

Biventricular ICD

DEVICEICD

Implantable Defibrillator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026