This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT
London Health Sciences Centre
London, Ontario, Canada
NTproBNP measurement
The co-primary outcome measure is NTproBNP as measured at 6 months.
Time frame: 6 Months
6-minute walk distance
The co-primary outcome measure is 6 minute hall walk distance as measured at 6 months.
Time frame: 6 Months
Quality of Life (QoL) score
The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.
Time frame: 6 Months
Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation
The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 6 months.
Time frame: 6 Months
LV reverse remodeling (LVESVi on echocardiography)
The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 6 months.
Time frame: 6 Months
LVEF
The secondary outcome measure is LVEF as measured by echocardiography at 6 months.
Time frame: 6 Months
A composite of all-cause mortality and HF events
The secondary outcome measure a composite of all-cause mortality and HF events at 6 months.
Time frame: 6 Months
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Packer Composite Clinical Outcome Score
The secondary outcome measure is Packer Composite Clinical Outcome Score at 6 months. The Packer Clinical Composite Score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined using clinical outcomes, heart failure status, and patient symptoms. Patients are considered improved if at the final visit they experienced in the patient assessment of a pre-specified scale but did not experience any major adverse clinical events throughout the trial. If considered worse, patients experienced a major clinical event during the planned duration of double-blind treatment or reported worsening at their final visit. And if considered unchanged, patients would be considered neither improved nor worse.
Time frame: 6 Months