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Myocardial Work and Metabolism in CRT | Clinical Trials | Clareo Health

UNKNOWNNA

Myocardial Work and Metabolism in CRT

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

NCT02537782•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+1 more criteria

Locations (2)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

September 1, 2015

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2023

Last Updated

January 9, 2020

Enrollment

200

ESTIMATED participants

Conditions

Left Ventricular DyssynchronyHeart FailureLeft Bundle Branch BlockCardiomyopathy

Interventions

Cardiac resynchronisation therapy

DEVICE

Echocardiography

OTHER

Magnetic Resonance Imaging

OTHER

Positron Emission Tomography

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Myocardial Work and Metabolism in CRT

Inclusion Criteria

Exclusion Criteria

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