Hypertrophic CardiomyopathiesNCT06859827
Role of CMR-FT in Assessment of HCM and Athlete's Heart.
An observational study of Hypertrophic Cardiomyopathies and Athlete Heart, run by Sohag University at 1 site in Egypt.
Trial summary
Using cardiac MRI feature tracking to asses myocardial motion differences in athlete's heart and discovered hypertrophic cardiomyopathy patients to increase diagnostic accuracy of hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathies, Athlete Heart
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Any age between 20 and 50 years either male or female with minor complains and suspected by Echo to be hypertrophic cardiomyopathy, athlete's exhibiting no symptoms.
Who may be able to join
- Patients suspected to be hypertrophic cardiomyopathy by echocardiography..
- Athletes and heavy workers,, healthy volunteers also included.
Who cannot join
- Patients with absolute or relative contraindications to magnetic resonance imaging (e.g intra-ocular metallic foreign body, claustrophobia, etc) or contra-indication to MRI contrast medium.
- Clinical morbidities with absolute contraindication to anesthesia during the examination in un-cooperative patients where sedation is required.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cardiac MRI Feature Tracking in Assessment of Hypertrophic Cardiomyopathy and Athlete's Heart.
Using cardiac MRI feature tracking to asses myocardial motion differences in athlete's heart and discovered hypertrophic cardiomyopathy patients to increase diagnostic accuracy of hypertrophic cardiomyopathy.
Read the detailed description
Cardiac MRI is the gold standard for assessing cardiac function without significant limitations of anatomical restrictions. CMR-FT helps in assessment of myocardial deformation on routinely obtained by steady state free precision (SSFP) cine images. CMR-FT is used in cardiac research and became common in clinical practice. It has been used in assessment of wide spectrum of cardiac diseases and provides for comprehensive and reliable assessments of heart function.
- Conditions
- Hypertrophic Cardiomyopathies, Athlete Heart
- Keywords
- Cardiac MRI feature tracking, Hypertrophic cardiomyopathy, Athlete's heart
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypertrophic cardiomyopathy patient | patient with hypertrophic cardiomyopathy | |
| Athlete's | Athlete's with thick myocardium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of cardiac MRI feature tracking in detection of myocardial deformation abnormalities and diagnostic confirmation and detection of hypertrophic cardiomyopathy.
The main goal of the study is evaluating the role of Cardiac magnetic resonance feature tracking analysis in detection of myocardial deformation abnormalities in cases of hypertrophic cardio myopathy and compare it with physiological hypertrophy in athletes.
Identification of strain patterns in hypertrophic cardiomyopathy.
Measured: 6months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Dec 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Abdelmageed Ragab, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859827
- Sponsor's protocol ID
- Soh-Med-25-2--MD
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cardiac MRI Feature Tracking in Assessment of Hypertrophic Cardiomyopathy and Athlete's Heart.
- ClinicalTrials.gov ID
- NCT06859827
- Acronym / sponsor ID
- Soh-Med-25-2--MD
- Conditions
- Hypertrophic Cardiomyopathies, Athlete Heart
- Keywords
- Cardiac MRI feature tracking, Hypertrophic cardiomyopathy, Athlete's heart
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 5 Mar 2025 (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.
Using cardiac MRI feature tracking to asses myocardial motion differences in athlete's heart and discovered hypertrophic cardiomyopathy patients to increase diagnostic accuracy of hypertrophic cardiomyopathy.
Detailed description
Cardiac MRI is the gold standard for assessing cardiac function without significant limitations of anatomical restrictions. CMR-FT helps in assessment of myocardial deformation on routinely obtained by steady state free precision (SSFP) cine images. CMR-FT is used in cardiac research and became common in clinical practice. It has been used in assessment of wide spectrum of cardiac diseases and provides for comprehensive and reliable assessments of heart function.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertrophic cardiomyopathy patient | – | –patient with hypertrophic cardiomyopathy |
| Athlete's | – | –Athlete's with thick myocardium |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Any age between 20 and 50 years either male or female with minor complains and suspected by Echo to be hypertrophic cardiomyopathy, athlete's exhibiting no symptoms.
Key inclusion criteria (2 listed)
- Patients suspected to be hypertrophic cardiomyopathy by echocardiography..
- Athletes and heavy workers,, healthy volunteers also included.
Key exclusion criteria (2 listed)
- Patients with absolute or relative contraindications to magnetic resonance imaging (e.g intra-ocular metallic foreign body, claustrophobia, etc) or contra-indication to MRI contrast medium.
- Clinical morbidities with absolute contraindication to anesthesia during the examination in un-cooperative patients where sedation is required.
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
Use of cardiac MRI feature tracking in detection of myocardial deformation abnormalities and diagnostic confirmation and detection of hypertrophic cardiomyopathy.
Time frame: 6months to 12 months
The main goal of the study is evaluating the role of Cardiac magnetic resonance feature tracking analysis in detection of myocardial deformation abnormalities in cases of hypertrophic cardio myopathy and compare it with physiological hypertrophy in athletes. Identification of strain patterns in hypertrophic cardiomyopathy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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.
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 Cardiomyopathies and Athlete Heart, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Use of cardiac MRI feature tracking in detection of myocardial deformation abnormalities and diagnostic confirmation and detection of hypertrophic cardiomyopathy. (time frame: 6months to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.