Cardiomyopathy, Heart Failure, Left Bundle Branch Block, Left Ventricular Dyssynchrony
Conditions
Keywords
Cardiac Resynchronisation Therapy, Heart Failure, Left ventricular dyssynchrony, Echocardiography, Apical rocking, Septal flash
Brief summary
Several attempts have been made to refine selection criteria for cardiac resynchronisation therapy (CRT) in heart failure patients with reduced ejection fraction (HFrEF). Previously proposed parameters probably do not sufficiently reflect the underlying mechanical dyssynchrony of the left ventricle (LV). Earlier work of our research group suggests that better candidate selection can rely on the direct observation or measurement of this LV mechanical dyssynchrony by means of non-invasive imaging. In this study apical rocking and other non-invasive measures of LV mechanical dyssynchrony will be applied to evaluate regional myocardial workload and metabolism, and determine their predictive value in CRT response.
Interventions
OTHEREchocardiography
OTHERMagnetic Resonance Imaging
OTHERPositron Emission Tomography
Sponsors
Oslo University Hospital
Universitaire Ziekenhuizen KU Leuven
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject is eligible for CRT implantation according to current European Society of Cardiology guidelines of 2013. * The patient should receive guideline-directed optimal medical therapy for heart failure and left ventricular (LV) function must be severely depressed (LV ejection fraction ≤35%). * The patients should be in NYHA functional class II, III or ambulatory IV. * The patient should present a left bundle branch block (LBBB) with QRS duration of \>120ms or a non-LBBB with QRS \>150ms. * Also patients with conventional pacemaker in NYHA functional class III and ambulatory IV if high percentage of ventricular pacing, are eligible for CRT implantation. * Subject is in stable sinus rhythm at the time of CRT implant and during the last 2 weeks prior to inclusion. * Subject is 18 years or older and able and willing to consent.
Exclusion criteria
* Impossible to obtain LV volumes by echocardiography. * Right bundle branch block. * Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm). * Recent myocardial infarction, within 40 days prior to enrolment. * Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days. * Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year. * Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year. * Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period). * Complex and uncorrected congenital heart disease. * Breastfeeding women, women of child bearing potential. * Enrolled in one or more concurrent studies that would confound the results of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac resynchronisation therapy (CRT) response assessed by echocardiography | Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation | Reduction in LVESV ≥15% from baseline |
| CRT response assessed by echocardiography | Change of LVESV between baseline and 12 months after CRT implantation | Reduction in LVESV ≥15% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA) class changes | Change of NYHA class between baseline, 6 and 12 months after CRT implantation | A decrease of ≥1 NYHA class |
| Functional capacity changes assessed by 6-minute walking test | Change of functional capacity between baseline and 6 months after CRT implantation | Assessed by 6-minute walking test |
| Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max) | Change of functional capacity between baseline and 6 months after CRT implantation | Assessed by peak oxygen uptake ergospirometry (VO2max) |
| Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography | Change of remodelling between baseline, 6 and 12 months after CRT implantation | Measured as changes in left ventricular volume by echocardiography |
| Heart failure related hospital admissions | Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation | — |
| Death | Assessment of possible death at 6 and 12 months after CRT implantation | Death by heart failure, sudden cardiac death and all-cause death |
| Quality of Life changes | Change of QoL between baseline, 6 and 12 months after CRT implantation | — |
| Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography | Change of remodelling between baseline, 6 and 12 months after CRT implantation | Measured as changes in left ventricular ejection fraction by echocardiography |
Countries
Belgium, Norway
Outcome results
None listed