Athlete's HeartNCT04970758
Differential Diagnosis Athlete's Heart From Cardiomyopathy
An observational study of Athlete's Heart, run by Peking University Third Hospital at 1 site in China.
Trial summary
Assess the effects of strength sport to heart structure and function by T1 mapping with cardiac resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athlete's Heart
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2019to 12 Dec 2020
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Athletes
Who may be able to join
- Same exercise
Who cannot join
- Intolerance test
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Differential Diagnosis Athlete's Heart From Hypertrophic Cardiomyopathy With T1 Mapping
Assess the effects of strength sport to heart structure and function by T1 mapping with cardiac resonance imaging.
- Conditions
- Athlete's Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
no intervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Athletes /strength exercise | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1 value in ms (Unit)
indicator of the degree of myocardial fibrosis
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start16 Jan 2019
- Primary completion1 Nov 2019
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athlete's HeartStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xinyu wang, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970758
- Sponsor's protocol ID
- M2019298
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis Athlete's Heart From Hypertrophic Cardiomyopathy With T1 Mapping
- ClinicalTrials.gov ID
- NCT04970758
- Acronym / sponsor ID
- M2019298
- Conditions
- Athlete's Heart
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 21 Jul 2021 (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.
Assess the effects of strength sport to heart structure and function by T1 mapping with cardiac resonance imaging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Athletes /strength exercise |
| control group | – | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Athletes
Key inclusion criteria (1 listed)
- Same exercise
Key exclusion criteria (1 listed)
- Intolerance test
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 |
|---|---|---|
| no intervention | Other | study group |
Primary outcome
T1 value in ms (Unit)
Time frame: one year
indicator of the degree of myocardial fibrosis
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 21 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Athlete's Heart
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Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)
Coronary Artery Disease, Atherosclerosis
Active, not recruitingObservational study
A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's
Hypertrophic Cardiomyopathy
RecruitingObservational study
Interaction Between Intraventricular Flow and Cardiac Mechanics Using 3D Echocardiography in Athletes and Sedentary Subjects
Athlete Heart
Active, not recruitingObservational study
Role of CMR-FT in Assessment of HCM and Athlete's Heart.
Hypertrophic Cardiomyopathies, Athlete Heart
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.
xinyu wang, MD principal investigator
Peking University Third Hospital
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 Athlete's Heart, run by Peking University Third Hospital at 1 site in China.
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 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: finished, as of the sponsor's last update on 21 Jul 2021. 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 China. 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?
T1 value in ms (Unit) (time frame: one year). 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 21 Jul 2021.