RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Improvements in 6-min walking distance
Study Overview
Brief Summary
Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.
We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.
Detailed Description
AIMS and Objectives A randomised controlled clinical trial
Primary objective
• Improvements in 6-min walking distance
Secondary objectives Determine
- Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
- Change in NT pro-BNP and echocardiographic parameters of LV function
- Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.
- Morbidity and Mortality using CARE-HF definitions
- Packer combined clinical composite score
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sinus rhythm
- •Symptomatic heart failure - NYHA class III or IV
- •ECG QRS duration less than 120 milliseconds
- •LV ejection fraction of less than 35% on echo
- •Able to give informed consent
Exclusion Criteria
- •Age below 18
- •Current or planned pregnancy
- •Patient refusal
- •Ventricular tachycardia or ventricular fibrillation
- •Current or recent (within last 30 days) involvement in other studies
- •Requires implantable cardioverter defibrillator (ICD)
Outcomes
Primary Outcomes
Improvements in 6-min walking distance
Time Frame: 6 months
Secondary Outcomes
- Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire(6 months)
- Does MRI Dyssynchrony Index (CMR-TSI) predicts responders(6 months)
- Change in NT pro-BNP and echocardiographic parameters of LV function(6 months)