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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02537782
Other study ID # S538235_v1.2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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