Hypertrophic CardiomyopathyNCT04112511
Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy
An observational study of Hypertrophic Cardiomyopathy, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias. Specifically the investigational questions are: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 250 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2015to 5 May 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include all patients with diagnosed hypertrophic cardiomyopathy that will proceed for assessment in AHEPA University Hospital. Only patients with severe valvular heart disease or prior myocardial infarction will be excluded
Who may be able to join
- -Patients with diagnosed hypertrophic cardiomyopathy
Who cannot join
- Concomitant severe valvular heart disease
- Prior myocardial infarction
- History of atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias.
Specifically the investigational questions are:
- Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy?
- Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?
Read the detailed description
Myocardial deformation parameters of the left heart chambers are of particular clinical importance because of their possible association with the severity of HCM and the presence of arrhythmias. However,current literature appears conflicting.
This is a prospective cohort study aiming to examine the echocardiographic parameters of myocardial deformation, estimated by the "speckle tracking" method, and their correlation with clinical presentation and symptomatology, other imaging parameters, exercise capacity, arrhythmias (ventricular or supraventricular) and risk factors for sudden death in patients with hypertrophic cardiomyopathy.
Although, similar efforts have been made in international literature, they are scarce and their results contradictory. The present study is the first to be performed in a Greek population, a fact that is particularly important given the genetic heterogeneity of the disease.
- Conditions
- Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac arrest
Documented ventricular fibrillation or sustained ventricular tachycardia
Measured: 3 years
Implantable cardioverter defibrillator therapy
Aproppriate Implantable cardioverter defibrillator therapy
Measured: 3 years
All cause mortality
Death by any cause
Measured: 3 years
Cardiovascular mortality
Death directly attributed to the primary disease
Measured: 3 years
Secondary outcomes (1)
Atrial fibrillation
Documented atrial fibrillation in patients with prior sinus rythm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Mar 2015
- Primary completion12 Dec 2021
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Zegkos, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112511
- Sponsor's protocol ID
- 4045PHD
- Status last verified
- Jul 2022
- First submitted
- 30 Sep 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zegkos T, Parcharidou D, Ntelios D, Efthimiadis G, Karvounis H. The Prognostic Implications of Two-Dimensional Speckle Tracking Echocardiography in Hypertrophic Cardiomyopathy: Current and Future Perspectives. Cardiol Rev. 2018 May/Jun;26(3):130-136. doi: 10.1097/CRD.0000000000000172.
PubMed 29045290Zegkos T, Ntelios D, Parcharidou D, Katranas S, Panagiotidis T, Papanastasiou CA, Karagiannidis E, Rouskas P, Vassilikos V, Karvounis H, Efthimiadis GK. The predictive value of left ventricular and left atrial mechanics for atrial fibrillation and heart failure in hypertrophic cardiomyopathy: a prospective cohort study. Int J Cardiovasc Imaging. 2021 Sep;37(9):2679-2690. doi: 10.1007/s10554-021-02232-0. Epub 2021 Apr 5.
PubMed 33818698
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Myocardial Deformation Parameters in Patients With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04112511
- Acronym / sponsor ID
- 4045PHD
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 2 Oct 2019 (actual)
- 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 purpose of the study is to investigate the potential correlations of global longitudinal strain and peak left atrial strain, measured by speckle tracking echocardiography with the severity of hypertrophic cardiomyopathy and the risk for arrhythmias.
Specifically the investigational questions are:
- Is there a correlation between myocardial deformation parameters of the left heart chambers with other important ultrasound parameters (eg maximal wall thickness, presence of subaortic obstruction, etc.) in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers and the symptomatology or functional capacity of patients with hypertrophic cardiomyopathy?
- Is there a correlation between the myocardial deformation parameters of the left heart chambers and the exercise capacity, as evidenced by the cardiopulmonary exercise test, in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers with the risk of ventricular or supraventricular arrhythmias in patients with hypertrophic cardiomyopathy?
- Is there a correlation between myocardial deformation parameters of the left heart chambers and risk factors for sudden death?
Detailed description
Myocardial deformation parameters of the left heart chambers are of particular clinical importance because of their possible association with the severity of HCM and the presence of arrhythmias. However,current literature appears conflicting.
This is a prospective cohort study aiming to examine the echocardiographic parameters of myocardial deformation, estimated by the "speckle tracking" method, and their correlation with clinical presentation and symptomatology, other imaging parameters, exercise capacity, arrhythmias (ventricular or supraventricular) and risk factors for sudden death in patients with hypertrophic cardiomyopathy.
Although, similar efforts have been made in international literature, they are scarce and their results contradictory. The present study is the first to be performed in a Greek population, a fact that is particularly important given the genetic heterogeneity of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all patients with diagnosed hypertrophic cardiomyopathy that will proceed for assessment in AHEPA University Hospital. Only patients with severe valvular heart disease or prior myocardial infarction will be excluded
Key inclusion criteria (1 listed)
- -Patients with diagnosed hypertrophic cardiomyopathy
Key exclusion criteria (3 listed)
- Concomitant severe valvular heart disease
- Prior myocardial infarction
- History of atrial fibrillation
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
Cardiac arrest
Time frame: 3 years
Documented ventricular fibrillation or sustained ventricular tachycardia
Implantable cardioverter defibrillator therapy
Time frame: 3 years
Aproppriate Implantable cardioverter defibrillator therapy
All cause mortality
Time frame: 3 years
Death by any cause
Cardiovascular mortality
Time frame: 3 years
Death directly attributed to the primary disease
1 secondary outcome
Atrial fibrillation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 29045290Zegkos T, Parcharidou D, Ntelios D, Efthimiadis G, Karvounis H. The Prognostic Implications of Two-Dimensional Speckle Tracking Echocardiography in Hypertrophic Cardiomyopathy: Current and Future Perspectives. Cardiol Rev. 2018 May/Jun;26(3):130-136. doi: 10.1097/CRD.0000000000000172.
- Derived from this study: PubMed 33818698Zegkos T, Ntelios D, Parcharidou D, Katranas S, Panagiotidis T, Papanastasiou CA, Karagiannidis E, Rouskas P, Vassilikos V, Karvounis H, Efthimiadis GK. The predictive value of left ventricular and left atrial mechanics for atrial fibrillation and heart failure in hypertrophic cardiomyopathy: a prospective cohort study. Int J Cardiovasc Imaging. 2021 Sep;37(9):2679-2690. doi: 10.1007/s10554-021-02232-0. Epub 2021 Apr 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by AHEPA University Hospital at 1 site in Greece.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 arrest (time frame: 3 years). The study lists 4 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 NCT04112511, which also lists 2 linked publications.
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 20 Jul 2022.