Myocardial Work and Metabolism in CRT

Not Applicable

• Conditions: Left Ventricular Dyssynchrony; Cardiomyopathy; Left Bundle Branch Block; Heart Failure
• Interventions: Device: Cardiac resynchronisation therapy; Other: Echocardiography; Other: Magnetic Resonance Imaging; Other: Positron Emission Tomography

• Registration Number: NCT02537782
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-02
• Primary Completion: 2018-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac resynchronisation therapy implantation	Echocardiography	Patients with current guideline-based indication for CRT implantation.
Cardiac resynchronisation therapy implantation	Magnetic Resonance Imaging	Patients with current guideline-based indication for CRT implantation.
Cardiac resynchronisation therapy implantation	Cardiac resynchronisation therapy	Patients with current guideline-based indication for CRT implantation.
Cardiac resynchronisation therapy implantation	Positron Emission Tomography	Patients with current guideline-based indication for CRT implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Quality of Life changes	Change of QoL between baseline, 6 and 12 months after CRT implantation
Heart failure related hospital admissions	Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
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)
Death	Assessment of possible death at 6 and 12 months after CRT implantation	Death by heart failure, sudden cardiac death and all-cause death

Trial Locations

Locations (2)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium

Oslo University Hospital; 🇳🇴 Oslo, Norway