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Myocardial Work and Metabolism in CRT (WORK-CRT)

Primary Purpose

Left Ventricular Dyssynchrony, Heart Failure, Left Bundle Branch Block

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cardiac resynchronisation therapy
Echocardiography
Magnetic Resonance Imaging
Positron Emission Tomography
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Left Ventricular Dyssynchrony focused on measuring Cardiac Resynchronisation Therapy, Heart Failure, Left ventricular dyssynchrony, Echocardiography, Apical rocking, Septal flash

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitaire Ziekenhuizen Leuven
  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cardiac resynchronisation therapy implantation

Arm Description

Patients with current guideline-based indication for CRT implantation.

Outcomes

Primary Outcome Measures

Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
Reduction in LVESV ≥15% from baseline
CRT response assessed by echocardiography
Reduction in LVESV ≥15% from baseline

Secondary Outcome Measures

Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography
Measured as changes in left ventricular volume by echocardiography
Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography
Measured as changes in left ventricular ejection fraction by echocardiography
New York Heart Association (NYHA) class changes
A decrease of ≥1 NYHA class
Functional capacity changes assessed by 6-minute walking test
Assessed by 6-minute walking test
Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)
Assessed by peak oxygen uptake ergospirometry (VO2max)
Quality of Life changes
Heart failure related hospital admissions
Death
Death by heart failure, sudden cardiac death and all-cause death

Full Information

First Posted
August 12, 2015
Last Updated
January 7, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02537782
Brief Title
Myocardial Work and Metabolism in CRT
Acronym
WORK-CRT
Official Title
Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dyssynchrony, Heart Failure, Left Bundle Branch Block, Cardiomyopathy
Keywords
Cardiac Resynchronisation Therapy, Heart Failure, Left ventricular dyssynchrony, Echocardiography, Apical rocking, Septal flash

7. Study Design

Study Phase
Not Applicable
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac resynchronisation therapy implantation
Arm Type
Other
Arm Description
Patients with current guideline-based indication for CRT implantation.
Intervention Type
Device
Intervention Name(s)
Cardiac resynchronisation therapy
Intervention Type
Other
Intervention Name(s)
Echocardiography
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Type
Other
Intervention Name(s)
Positron Emission Tomography
Primary Outcome Measure Information:
Title
Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
Description
Reduction in LVESV ≥15% from baseline
Time Frame
Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation
Title
CRT response assessed by echocardiography
Description
Reduction in LVESV ≥15% from baseline
Time Frame
Change of LVESV between baseline and 12 months after CRT implantation
Secondary Outcome Measure Information:
Title
Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography
Description
Measured as changes in left ventricular volume by echocardiography
Time Frame
Change of remodelling between baseline, 6 and 12 months after CRT implantation
Title
Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography
Description
Measured as changes in left ventricular ejection fraction by echocardiography
Time Frame
Change of remodelling between baseline, 6 and 12 months after CRT implantation
Title
New York Heart Association (NYHA) class changes
Description
A decrease of ≥1 NYHA class
Time Frame
Change of NYHA class between baseline, 6 and 12 months after CRT implantation
Title
Functional capacity changes assessed by 6-minute walking test
Description
Assessed by 6-minute walking test
Time Frame
Change of functional capacity between baseline and 6 months after CRT implantation
Title
Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)
Description
Assessed by peak oxygen uptake ergospirometry (VO2max)
Time Frame
Change of functional capacity between baseline and 6 months after CRT implantation
Title
Quality of Life changes
Time Frame
Change of QoL between baseline, 6 and 12 months after CRT implantation
Title
Heart failure related hospital admissions
Time Frame
Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
Title
Death
Description
Death by heart failure, sudden cardiac death and all-cause death
Time Frame
Assessment of possible death at 6 and 12 months after CRT implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens-Uwe Voigt, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Otto A Smiseth, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0372
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31820130
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.
Results Reference
derived

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Myocardial Work and Metabolism in CRT

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