Hearts of Athletes

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.

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 Overview

• Status: Terminated
• Conditions: Cardiac Involvement With COVID-19

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Athletes with COVID-19
Athletes without COVID-19 (control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Definite Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)	Up to 7 months
Rate of Possible Myocarditis as measured by CMR (Cardiac Magnetic Resonance Imaging)	Up to 7 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of abnormal ECGs as measured by medical record abstraction	Up to 7 months
Number of abnormal Troponin as measured by medical record abstraction	Up to 7 months
Number of abnormal echocardiogram as measured by medical record abstraction	Up to 7 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: The Joel Cornette Foundation
• Investigators: Principal Investigator: Manesh Patel, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): September 24, 2025

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: athletes
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pro00106943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No