Myocardial Work and Metabolism in CRT

Overview

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.

Full Title of Study: “Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population”

Study Type

  • Study Type: Interventional
  • Study Primary Completion Date: December 1, 2018

Interventions

  • Device: Cardiac resynchronisation therapy
  • Other: Echocardiography
  • Other: Magnetic Resonance Imaging
  • Other: Positron Emission Tomography

Arms, Groups and Cohorts

  • Other: Cardiac resynchronisation therapy implantation
    • Patients with current guideline-based indication for CRT implantation.

Clinical Trial Outcome Measures

Primary Measures

  • Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
    • Time Frame: 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
    • Time Frame: Change of LVESV between baseline and 12 months after CRT implantation
    • Reduction in LVESV ≥15% from baseline

Secondary Measures

  • Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography
    • Time Frame: 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
    • Time Frame: Change of remodelling between baseline, 6 and 12 months after CRT implantation
    • Measured as changes in left ventricular ejection fraction by echocardiography
  • New York Heart Association (NYHA) class changes
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: Change of functional capacity between baseline and 6 months after CRT implantation
    • Assessed by peak oxygen uptake ergospirometry (VO2max)
  • Quality of Life changes
    • Time Frame: Change of QoL between baseline, 6 and 12 months after CRT implantation
  • Heart failure related hospital admissions
    • Time Frame: Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
  • Death
    • Time Frame: Assessment of possible death at 6 and 12 months after CRT implantation
    • Death by heart failure, sudden cardiac death and all-cause death

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen KU Leuven
  • Collaborator
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: prof. dr. Jens-Uwe Voigt, prof. dr. – Universitaire Ziekenhuizen KU Leuven
  • Overall Official(s)
    • Jens-Uwe Voigt, MD, PhD, Principal Investigator, Universitaire Ziekenhuizen KU Leuven
    • Otto A Smiseth, MD, PhD, Principal Investigator, Oslo University Hospital

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