Myocardial Work and Metabolism in CRT

NCT02537782 | Unknown

• 1 other identifier: S538235_v1.2
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Cardiac resynchronisation therapy (CRT) response assessed by echocardiography

  Reduction in LVESV ≥15% from baseline

  Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation

• CRT response assessed by echocardiography

  Reduction in LVESV ≥15% from baseline

  Change of LVESV between baseline and 12 months after CRT implantation

Secondary Outcomes (8)

• 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

• 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

• New York Heart Association (NYHA) class changes

  Change of NYHA class between baseline, 6 and 12 months after CRT implantation

• Functional capacity changes assessed by 6-minute walking test

  Change of functional capacity between baseline and 6 months after CRT implantation

• Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)

  Change of functional capacity between baseline and 6 months after CRT implantation

Study Arms (1)

Cardiac resynchronisation therapy implantation

OTHER

Patients with current guideline-based indication for CRT implantation.

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

Interventions

Cardiac resynchronisation therapy DEVICE

Cardiac resynchronisation therapy implantation

Echocardiography OTHER

Cardiac resynchronisation therapy implantation

Magnetic Resonance Imaging OTHER

Cardiac resynchronisation therapy implantation

Positron Emission Tomography OTHER

Cardiac resynchronisation therapy implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 18 years or older and able and willing to consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Oslo University Hospital

Oslo, 0372, Norway

Location

Related Publications (1)

• 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.

  PMID: 31820130 DERIVED

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block; Cardiomyopathies

Interventions

Cardiac Resynchronization Therapy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jens-Uwe Voigt, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Otto A Smiseth, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2023
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

BE (1); NO (1)