Left Ventricular DyssynchronyWORK-CRTNCT02537782
Myocardial Work and Metabolism in CRT
A study testing Cardiac resynchronisation therapy, Echocardiography and Magnetic Resonance Imaging in people with Left Ventricular Dyssynchrony and Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dyssynchrony, Heart Failure, Left Bundle Branch Block
- What is being tested?
- Cardiac resynchronisation therapy, Echocardiography and Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population
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.
- Being tested
- Cardiac resynchronisation therapy, Echocardiography, Magnetic Resonance Imaging, Positron Emission Tomography
- Keywords
- Cardiac Resynchronisation Therapy, Heart Failure, Left ventricular dyssynchrony, Echocardiography, Apical rocking, Septal flash
- Medical subject headings
- Heart Failure, Bundle-Branch Block, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronisation therapyDevice
EchocardiographyOther
Magnetic Resonance ImagingOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiac resynchronisation therapy implantation | Other | Patients with current guideline-based indication for CRT implantation. Receives: Device: Cardiac resynchronisation therapy; Other: Echocardiography; Other: Magnetic Resonance Imaging; Other: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
Reduction in LVESV ≥15% from baseline
Measured: 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
Measured: 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
Measured as changes in left ventricular volume by echocardiography
Measured: 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
Measured as changes in left ventricular ejection fraction by echocardiography
Measured: Change of remodelling between baseline, 6 and 12 months after CRT implantation
New York Heart Association (NYHA) class changes
A decrease of ≥1 NYHA class
Measured: Change of NYHA class between baseline, 6 and 12 months after CRT implantation
Functional capacity changes assessed by 6-minute walking test
Assessed by 6-minute walking test
Measured: Change of functional capacity between baseline and 6 months after CRT implantation
Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)
Assessed by peak oxygen uptake ergospirometry (VO2max)
Measured: Change of functional capacity between baseline and 6 months after CRT implantation
Quality of Life changes
Measured: Change of QoL between baseline, 6 and 12 months after CRT implantation
Heart failure related hospital admissions
Measured: Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
Death
Death by heart failure, sudden cardiac death and all-cause death
Measured: Assessment of possible death at 6 and 12 months after CRT implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion1 Dec 2018
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DyssynchronyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, prof. dr. Jens-Uwe Voigt, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jens-Uwe Voigt, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenOtto A Smiseth, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537782
- Sponsor's protocol ID
- S538235_v1.2
- Acronym
- WORK-CRT
- Status last verified
- Jan 2020
- First submitted
- 12 Aug 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31820130
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Inhomogeneities of Regional Myocardial WORKload and Metabolism in a Cardiac Resynchronisation Therapy Patient Population
- ClinicalTrials.gov ID
- NCT02537782
- Acronym / sponsor ID
- WORK-CRT / S538235_v1.2
- Keywords
- Cardiac Resynchronisation Therapy, Heart Failure, Left ventricular dyssynchrony, Echocardiography, Apical rocking, Septal flash
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Sep 2015
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac resynchronisation therapy implantation | Other | Device: Cardiac resynchronisation therapy, Other: Echocardiography, Other: Magnetic Resonance Imaging, Other: Positron Emission TomographyPatients with current guideline-based indication for CRT implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Cardiac resynchronisation therapy (CRT) response assessed by echocardiography
Time frame: Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation
Reduction in LVESV ≥15% from baseline
CRT response assessed by echocardiography
Time frame: Change of LVESV between baseline and 12 months after CRT implantation
Reduction in LVESV ≥15% from baseline
8 secondary outcomes
Reverse left ventricular remodelling measured as changes in left ventricular volume by echocardiography
Time frame: 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
Time frame: Change of remodelling between baseline, 6 and 12 months after CRT implantation
New York Heart Association (NYHA) class changes
Time frame: Change of NYHA class between baseline, 6 and 12 months after CRT implantation
Functional capacity changes assessed by 6-minute walking test
Time frame: Change of functional capacity between baseline and 6 months after CRT implantation
Functional capacity changes assessed by peak oxygen uptake ergospirometry (VO2max)
Time frame: Change of functional capacity between baseline and 6 months after CRT implantation
Quality of Life changes
Time frame: Change of QoL between baseline, 6 and 12 months after CRT implantation
Heart failure related hospital admissions
Time frame: Assessment of the number of hospital admissions at 6 and 12 months after CRT implantation
Death
Time frame: Assessment of possible death at 6 and 12 months after CRT implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Derived from this study: PubMed 31820130Degtiarova 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.
Related trials for Left Ventricular Dyssynchrony
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AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT
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Recruiting
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
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COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Uwe Voigt, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Otto A Smiseth, MD, PhD principal investigator
Oslo University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronisation therapy, Echocardiography and Magnetic Resonance Imaging in people with Left Ventricular Dyssynchrony and Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac resynchronisation therapy (CRT) response assessed by echocardiography (time frame: Change of left ventricular end-systolic volume (LVESV) between baseline and 6 months after CRT implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.