Left Ventricular Function Systolic DysfunctionNCT02286908
Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction
An observational study of Left Ventricular Function Systolic Dysfunction, run by Oslo University Hospital at 8 sites in 2 countries.
Trial summary
The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Function Systolic Dysfunction
- How many people
- 3,100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jun 2014to Dec 2025
- Phase
- Observational
- 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
Study population: Patients with myocardial infarction, heart failure and patients planned for primary prophylactic ICD. Echocardiography is performed at inclusion. Comparism of the ability of left ventricular ejection fraction, global strain and mechanical dispersion to predict clinical outcome in patients with these conditions.
Who may be able to join
- All patients with
- myocardial infarction
- heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray.
- planned for primary prophylactic ICD
- over 18 years of age
- Informed consent
Who cannot join
- -
Trial locations and contacts
8 sites in 2 countries.
Thor Edvardsen, MD, PHD contact
Harald Brunvand, MD, PHD contact
8 sites in 2 countries
Norway7 sites, 7 recruiting
- Recruiting
Sørlandet sykehus HF
Arendal, Agder, 4800
Daniela Melichova, MD, daniela.melichova@sshf.no
Thuy Mi Nguyen, MD, nguyenthuymi@gmail.com
- Recruiting
Vestre Viken HF
Drammen, 3004
Erik Gjertsen
- Recruiting
Sørlandet sykehus Kristiansand
Kristiansand, 4604
Tor Olav Isaksen
- Recruiting
Oslo university hospital
Oslo
Thor Edvardsen, MD, PhD, thor.edvardsen@medisin.uio.no
Lars Gunnar Klæboe, MD
- Recruiting
Sykehuset Telemark HF
Skien, 3710
Jacob Thalamus
- Recruiting
Stavanger universitetssjukehus
Stavanger, 4068
Dennis Nilsen
- Recruiting
Universitetssykehuset Nord Norge, Tromsø
Tromsø, 9038
Pål Tande
Henrik Schirmer
Czechia1 site, 1 recruiting
- Recruiting
Vseobecna fakultni nemocnice Praha/ Prague General hospital
Prague
Josef Marek, jsfmarek@gmail.com
About this study
Official title: Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure
The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause.
Read the detailed description
- The main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure.
- In patients who receive internal cardioverter defibrillator(ICD) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than EF.
- No interventions,only evaluation of the measurements obtained with transthoracic echocardiography.
- Follow up for 3 years, extended from 3 to 5 years.
- Keywords
- Ejection fraction, Global Strain, Mechanical dispersion
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmia and death after acute myocardial infarction or heart failure.
Arrhythmic events during follow-up are defined as documented sustained ventricular tachycardia, ventricular fibrillation, and SCD. Survival is assessed by medical charts if patients are within the uptake area of the hospital and by the Norwegian death registry Folkeregisteret.
Measured: 5 years or more
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (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 Function Systolic DysfunctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Thor Edvardsen, Oslo University Hospital
- Investigators
- Thor Edvardsen, MD, PHD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286908
- Sponsor's protocol ID
- 2013/573/REK sør-øst
- Status last verified
- Nov 2023
- First submitted
- 22 Aug 2014
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Nguyen TM, Melichova D, Aabel EW, Salte IM, Gjertsen E, Heggelund G, Kleiven O, Brunvand H, Edvardsen T, Haugaa K. Temporal trends in the primary prevention of implantable cardioverter-defibrillator selection and long-term outcomes in patients with non-ischaemic dilated cardiomyopathy and ischaemic cardiomyopathy. Europace. 2026 Mar 30;28(4):euag062. doi: 10.1093/europace/euag062.
PubMed 41955288
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure
- ClinicalTrials.gov ID
- NCT02286908
- Acronym / sponsor ID
- 2013/573/REK sør-øst
- Keywords
- Ejection fraction, Global Strain, Mechanical dispersion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Nov 2014 (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.
The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause.
Detailed description
- The main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure.
- In patients who receive internal cardioverter defibrillator(ICD) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than EF.
- No interventions,only evaluation of the measurements obtained with transthoracic echocardiography.
- Follow up for 3 years, extended from 3 to 5 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myocardial infarction, heart failure and patients planned for primary prophylactic ICD. Echocardiography is performed at inclusion. Comparism of the ability of left ventricular ejection fraction, global strain and mechanical dispersion to predict clinical outcome in patients with these conditions.
Key inclusion criteria (6 listed)
- All patients with
- over 18 years of age
- Informed consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventricular arrhythmia and death after acute myocardial infarction or heart failure.
Time frame: 5 years or more
Arrhythmic events during follow-up are defined as documented sustained ventricular tachycardia, ventricular fibrillation, and SCD. Survival is assessed by medical charts if patients are within the uptake area of the hospital and by the Norwegian death registry Folkeregisteret.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 41955288Nguyen TM, Melichova D, Aabel EW, Salte IM, Gjertsen E, Heggelund G, Kleiven O, Brunvand H, Edvardsen T, Haugaa K. Temporal trends in the primary prevention of implantable cardioverter-defibrillator selection and long-term outcomes in patients with non-ischaemic dilated cardiomyopathy and ischaemic cardiomyopathy. Europace. 2026 Mar 30;28(4):euag062. doi: 10.1093/europace/euag062.
- Individual participant dataSharing planned: Undecided
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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.
Thor Edvardsen, MD, PHD contact
Harald Brunvand, MD, PHD contact
Thor Edvardsen, MD, PHD study director
Oslo University Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Function Systolic Dysfunction, run by Oslo University Hospital at 8 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 6 inclusion and 1 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway, Czechia. 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?
Contact Thor Edvardsen, MD, PHD (thor.edvardsen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmia and death after acute myocardial infarction or heart failure. (time frame: 5 years or more). 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 NCT02286908, 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 13 Nov 2023.