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

NCT01100918 | Completed Phase 4

• 1 other identifier: 004844BLT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Cardiac resynchronisation therapy; Tissue Doppler Imaging; Dyssynchrony

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (3)

• 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

Study Arms (3)

1: Dyssynchrony positive

ACTIVE COMPARATOR

Device: BiV ICD

2a: Dyssynchrony negative

ACTIVE COMPARATOR

Device: BiV ICD

2b: Dyssynchrony negative

ACTIVE COMPARATOR

Device: ICD

Interventions

BiV ICD DEVICE

Biventricular ICD

1: Dyssynchrony positive; 2a: Dyssynchrony negative

ICD DEVICE

Implantable Defibrillator

2b: Dyssynchrony negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Richard Schilling, MD, FRCP

  Barts and the London NHS Trust, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: February 1, 2007
• Study Completion: December 1, 2010
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (1)