Cardiac Involvement With COVID-19NCT04736004
Hearts of Athletes
An observational study of Cardiac Involvement With COVID-19, run by Duke University at 1 site in United States.
Trial summary
The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater) Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cardiac Involvement With COVID-19
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 24 Sep 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 to 30 years
- All sexes
- Adult
Study population: Any adult athlete, defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete, with COVID-19 compared to any adult athlete without COVID-19.
Who may be able to join
- Any adult athlete (defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete) will be eligible for the study.
- COVID-19 diagnosed via an RT-PCR, or history of COVID-19 antibodies at least 10 days and less than 6 months prior to consent
- No longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation.
- Identification as a Control participant (similar sport) to a participant without COVID-19 willing to undergo cardiovascular evaluation
Who cannot join
- Anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease
- Anyone without the ability to provide informed consent
- Anyone with a known contraindication to cardiac magnetic resonance (metallic implant)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)
- Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study.
Read more
With COVID-19
- COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment
Or without COVID-19
- Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation
Participants with and without COVID-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. Also, participants will allow their de-identified cardiac images to be sent to the Duke Heart Center for blinded analysis.
No physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality.
- Conditions
- Cardiac Involvement With COVID-19
- Keywords
- athletes
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 |
|---|---|---|
| Athletes with COVID-19 | Not described | |
| Athletes without COVID-19 (control) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Measured: Up to 7 months
Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Measured: Up to 7 months
Secondary outcomes (3)
Number of abnormal ECGs as measured by medical record abstraction
Measured: Up to 7 months
Number of abnormal Troponin as measured by medical record abstraction
Measured: Up to 7 months
Number of abnormal echocardiogram as measured by medical record abstraction
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 Nov 2022
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Why it stopped: Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Involvement With COVID-19Studies of the same condition, open and under way.
- More trials run by Duke 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-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Joel Cornette Foundation
- Responsible party
- Sponsor
- Investigators
- Manesh Patel, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736004
- Sponsor's protocol ID
- Pro00106943
- Status last verified
- Sep 2025
- First submitted
- 29 Jan 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearts of Athletes Study: Prospective Evaluation of Athletes for Cardiac Involvement With COVID-19
- ClinicalTrials.gov ID
- NCT04736004
- Acronym / sponsor ID
- Pro00106943
- Conditions
- Cardiac Involvement With COVID-19
- Keywords
- athletes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Joel Cornette Foundation
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 3 Feb 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.
The Hearts of Athletes study is being conducted to determine the heart involvement with COVID-19 in athletes. This study aims to enroll any Adult (18 years of age or greater)
- Athlete is defined as NCAA Collegiate Athlete, Professional Athlete, Military, or Olympic Athlete will be eligible for the study.
With COVID-19
- COVID-19 diagnosed via an RT-PCR (nasal or throat swab test) prior to enrollment
Or without COVID-19
- Identified as a local Control participant (similar sport) to a participant with COVID-19, who is willing to undergo a standard cardiovascular evaluation
Participants with and without COVID-19 will use their mobile devices to provide health information, like symptoms, by answering survey questions daily for 30 days. Also, participants will allow their de-identified cardiac images to be sent to the Duke Heart Center for blinded analysis.
No physical risks are associated with this study. One possible risk, although minimal, is loss of confidentiality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes with COVID-19 | – | – |
| Athletes without COVID-19 (control) | – | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Any adult athlete, defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete, with COVID-19 compared to any adult athlete without COVID-19.
Key inclusion criteria (4 listed)
- Any adult athlete (defined as NCAA Collegiate Athlete, Professional Athlete, or Olympic Athlete) will be eligible for the study.
- COVID-19 diagnosed via an RT-PCR, or history of COVID-19 antibodies at least 10 days and less than 6 months prior to consent
- No longer requiring quarantine per local health recommendations, prior to cardiovascular evaluation.
- Identification as a Control participant (similar sport) to a participant without COVID-19 willing to undergo cardiovascular evaluation
Key exclusion criteria (3 listed)
- Anyone with known cardiovascular disease - defined as known myocardial disease, valvular heart disease, or known coronary heart disease
- Anyone without the ability to provide informed consent
- Anyone with a known contraindication to cardiac magnetic resonance (metallic implant)
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
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Time frame: Up to 7 months
Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)
Time frame: Up to 7 months
3 secondary outcomes
Number of abnormal ECGs as measured by medical record abstraction
Time frame: Up to 7 months
Number of abnormal Troponin as measured by medical record abstraction
Time frame: Up to 7 months
Number of abnormal echocardiogram as measured by medical record abstraction
Time frame: Up to 7 months
Results and safety
The study was stopped early (reason given: Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiac Involvement With COVID-19
Active, not recruitingPhase 3
Myocardial Protection in Patients With Post-acute Inflammatory Cardiac Involvement Due to COVID-19
COVID-19 Associated Cardiac Involvement, Remodeling, Left Ventricle
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.
Manesh Patel, MD principal investigator
Duke University
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 Cardiac Involvement With COVID-19, run by Duke University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 2 Oct 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 United States. 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 was stopped early (reason given: Study terminated due to insufficient participant enrollment during the COVID-19 pandemic, which impacted recruitment timelines and feasibility of meeting study objectives.). 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?
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging) (time frame: Up to 7 months). 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?
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 2 Oct 2025.