Clinical trial NCT02537782: Myocardial Work and Metabolism in CRT
Official title: Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Left Ventricular Dyssynchrony
Heart Failure
Left Bundle Branch Block
Cardiomyopathy
Keywords: Cardiac Resynchronisation Therapy
Heart Failure
Left ventricular dyssynchrony
Echocardiography
Apical rocking
Septal flash
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2015-09-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
timeFrame: Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation
measure: CRT response assessed by echocardiography
timeFrame: Change of LVESV between baseline and 12 months after CRT implantation
Secondary outcomes:
measure: Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography
timeFrame: Change of remodelling between baseline, 6 and 12 months after CRT implantation
measure: Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography
timeFrame: Change of remodelling between baseline, 6 and 12 months after CRT implantation
measure: New York Heart Association (NYHA) class changes
timeFrame: Change of NYHA class between baseline, 6 and 12 months after CRT implantation
measure: Functional capacity changes assessed by 6-minute walking test
timeFrame: Change of functional capacity between baseline and 6 months after CRT implantation
measure: Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)
timeFrame: Change of functional capacity between baseline and 6 months after CRT implantation
measure: Quality of Life changes
timeFrame: Change of QoL between baseline, 6 and 12 months after CRT implantation
measure: Heart failure related hospital admissions
timeFrame: Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
measure: Death
timeFrame: Assessment of possible death at 6 and 12 months after CRT implantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jens-Uwe Voigt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Otto A Smiseth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Degtiarova G, Claus P, Duchenne J, Cvijic M, Schramm G, Nuyts J, Voigt JU, Gheysens O. Low septal to lateral wall 18F-FDG ratio is highly associated with mechanical dyssynchrony in non-ischemic CRT candidates. EJNMMI Res. 2019 Dec 9;9(1):105. doi: 10.1186/s13550-019-0575-9.