Myocardial Work and Metabolism in CRT

Heart Failure Clinical Trial

— WORK-CRT  

Official title:

Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02537782
• Other study ID #: S538235_v1.2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bundle-Branch Block
• Cardiomyopathies
• Cardiomyopathy
• Heart Failure
• Left Bundle Branch Block
• Left Ventricular Dyssynchrony

Intervention

Device:
• Cardiac resynchronisation therapy

Other:
• Echocardiography

• Magnetic Resonance Imaging

• Positron Emission Tomography

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Oslo University Hospital

Countries where clinical trial is conducted

Belgium,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	CRT response assessed by echocardiography	Reduction in LVESV =15% from baseline	Change of LVESV between baseline and 12 months after CRT implantation
Secondary	Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography	Measured as changes in left ventricular volume by echocardiography	Change of remodelling between baseline, 6 and 12 months after CRT implantation
Secondary	Reverse left ventricular remodelling measured as changes in left ventricular ejection fraction by echocardiography	Measured as changes in left ventricular ejection fraction by echocardiography	Change of remodelling between baseline, 6 and 12 months after CRT implantation
Secondary	New York Heart Association (NYHA) class changes	A decrease of =1 NYHA class	Change of NYHA class between baseline, 6 and 12 months after CRT implantation
Secondary	Functional capacity changes assessed by 6-minute walking test	Assessed by 6-minute walking test	Change of functional capacity between baseline and 6 months after CRT implantation
Secondary	Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)	Assessed by peak oxygen uptake ergospirometry (VO2max)	Change of functional capacity between baseline and 6 months after CRT implantation
Secondary	Quality of Life changes		Change of QoL between baseline, 6 and 12 months after CRT implantation
Secondary	Heart failure related hospital admissions		Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
Secondary	Death	Death by heart failure, sudden cardiac death and all-cause death	Assessment of possible death at 6 and 12 months after CRT implantation