Athlete HeartRemodNCT05555849
Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining
An observational study of Athlete Heart and Arrhythmias, Cardiac, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Exercise has many well-documented effects in the prevention or treatment of disease, but recently some studies have raised awareness of the possible negative effects of too much exercise. In former elite endurance athletes, an increased risk of cardiac fibrosis and arrhythmias have been described. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Athlete Heart, Arrhythmias, Cardiac
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2022to 1 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy danish elite athletes over the age of 18, who recently retired from elitesports.
Who may be able to join
- ≥18 years at the time of screening
- Former elite athlete from endurance sport discipline
- End of elite sporting career >1 year ago
Who cannot join
- Any known cardiac disease
- Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could impose the subject at significant risk, or interfere significantly with the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Exercise has many well-documented effects in the prevention or treatment of disease, but recently some studies have raised awareness of the possible negative effects of too much exercise. In former elite endurance athletes, an increased risk of cardiac fibrosis and arrhythmias have been described. Whether exercise itself is the culprit remains to be explored.
The right cardiac ventricle can be overloaded during long-term intense exercise, due to increased volume load and possibly an increased afterload. In a subgroub of athletes the appearance with morphological and functional changes resembling an ARVC like phenotype. Furthermore, atrial fibrillation among male middle-aged athletes is up to 5 times more common compared to age-matched non-athletes. The working hypothesis of this study is that male athletes remodel more than females and that some of thise changes are already measureable early after end of elite sporting carreer.
In this prospective cohort study, of 50 elite athletes at retirement, after 3 months and thereafter yearly for five years, to determine the characteristics of remodeling of the heart focusing on the left atrial and right ventricle.
Read the detailed description
A prospective cohort study of reverse cardiac remodeling in recently retired elite athletes
Aim To explore the remodeling of the heart focusing on right ventricle and left atria as well as pulmonary circulation in elite athletes at rest and during exercise as well as the effect of short and long-term reverse remodeling after the end of a professional sporting career
Methods The investigators will initiate a 5-year longitudinal study of cardiac detraining in 50 former elite athletes.
Primary outcome Change in left atrial minimum size after three months retirement (mL)
Secondary outcome:
- Change in left atrium (LA) function measured by strain and volume measures by echocardiography and magnetic resonance cor (MRc) after three months and the following years
- Change in right and left ventricle size and function by echocardiography and magnetic resonance cor (MRc) after three months and the following years
- Change in VO2max after three months and the following years
- Change in diurnal ventricular and supraventricular ectopy and heart rate variability after three months and the following years
- Change in blood pressure, BMI after three months and the following years
- Change in plasma lipids and HbA1c after three months and the following years
The full list of examinations includes:
- Baseline family history, medical and training history
- Cardio-pulmonary exercise test
- 24-hour Holter monitoring
- Biochemistry
- Cardiac MR including contrast at rest and during exercise
- Trans thoracic echocardiography
Project organization and partners Recruitment of participants is organized in cooperation with the danish national elite sports organization (Team Danmark), Divisionsforeningen (The association of professional football clubs), and Spillerforeningen (The union of professional football players).
- Conditions
- Athlete Heart, Arrhythmias, Cardiac
- Medical subject headings
- Arrhythmias, Cardiac
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 |
|---|---|---|
| Study group, Newly retired elite athletes | Elite athletes at the time of retirement of professional career. Reinvestigated after three months and thereafter yearly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial minimum volume
Primary endpoint The primary aim is to assess the long-term effect on remodeling of left atrium size measured by 2D echocardiography
- Primary endpoint: Change in LA minimum volume (mL)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 May 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athlete HeartStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Hanne Kruuse Rasmusen, Bispebjerg Hospital
- Investigators
- Hanne K Rasmusen, ph.d., Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555849
- Sponsor's protocol ID
- H-21043707
- Acronym
- Remod
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Registration After the provision of informed consent, each subject will be registered in a logged web-based register (REDCap). A list of registered participants will be kept linking the subject identification number. This list will be entered in a separate database and data will be encrypted. Information will not be passed on to a third party. Bispebjerg-Frederiksberg department of cardiology supervised by consultant doctor Hanne Kruuse Rasmusen will have the overall ownership and intellectual property rights to data collected in during this project.
Publications
Aaroee M, Tischer SG, Christensen R, Sajadieh A, Dall CH, Thune JJ, Rasmusen H. Long-term left atrial adaptations to reduced training load in former elite athletes: a long-term follow-up longitudinal observational study. BMJ Open Sport Exerc Med. 2025 Apr 3;11(2):e002379. doi: 10.1136/bmjsem-2024-002379. eCollection 2025.
PubMed 40191843
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining
- ClinicalTrials.gov ID
- NCT05555849
- Acronym / sponsor ID
- Remod / H-21043707
- Conditions
- Athlete Heart, Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 27 Sep 2022 (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.
Exercise has many well-documented effects in the prevention or treatment of disease, but recently some studies have raised awareness of the possible negative effects of too much exercise. In former elite endurance athletes, an increased risk of cardiac fibrosis and arrhythmias have been described. Whether exercise itself is the culprit remains to be explored.
The right cardiac ventricle can be overloaded during long-term intense exercise, due to increased volume load and possibly an increased afterload. In a subgroub of athletes the appearance with morphological and functional changes resembling an ARVC like phenotype. Furthermore, atrial fibrillation among male middle-aged athletes is up to 5 times more common compared to age-matched non-athletes. The working hypothesis of this study is that male athletes remodel more than females and that some of thise changes are already measureable early after end of elite sporting carreer.
In this prospective cohort study, of 50 elite athletes at retirement, after 3 months and thereafter yearly for five years, to determine the characteristics of remodeling of the heart focusing on the left atrial and right ventricle.
Detailed description
A prospective cohort study of reverse cardiac remodeling in recently retired elite athletes
Aim To explore the remodeling of the heart focusing on right ventricle and left atria as well as pulmonary circulation in elite athletes at rest and during exercise as well as the effect of short and long-term reverse remodeling after the end of a professional sporting career
Methods The investigators will initiate a 5-year longitudinal study of cardiac detraining in 50 former elite athletes.
Primary outcome Change in left atrial minimum size after three months retirement (mL)
Secondary outcome:
- Change in left atrium (LA) function measured by strain and volume measures by echocardiography and magnetic resonance cor (MRc) after three months and the following years
- Change in right and left ventricle size and function by echocardiography and magnetic resonance cor (MRc) after three months and the following years
- Change in VO2max after three months and the following years
- Change in diurnal ventricular and supraventricular ectopy and heart rate variability after three months and the following years
- Change in blood pressure, BMI after three months and the following years
- Change in plasma lipids and HbA1c after three months and the following years
The full list of examinations includes:
- Baseline family history, medical and training history
- Cardio-pulmonary exercise test
- 24-hour Holter monitoring
- Biochemistry
- Cardiac MR including contrast at rest and during exercise
- Trans thoracic echocardiography
Project organization and partners Recruitment of participants is organized in cooperation with the danish national elite sports organization (Team Danmark), Divisionsforeningen (The association of professional football clubs), and Spillerforeningen (The union of professional football players).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group, Newly retired elite athletes | – | –Elite athletes at the time of retirement of professional career. Reinvestigated after three months and thereafter yearly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy danish elite athletes over the age of 18, who recently retired from elitesports.
Key inclusion criteria (3 listed)
- ≥18 years at the time of screening
- Former elite athlete from endurance sport discipline
- End of elite sporting career >1 year ago
Key exclusion criteria (2 listed)
- Any known cardiac disease
- Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could impose the subject at significant risk, or interfere significantly with the subject's participation in the study.
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
Left atrial minimum volume
Time frame: 5 years
Primary endpoint The primary aim is to assess the long-term effect on remodeling of left atrium size measured by 2D echocardiography • Primary endpoint: Change in LA minimum volume (mL)
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 5 Sep 2024.
- Derived from this study: PubMed 40191843Aaroee M, Tischer SG, Christensen R, Sajadieh A, Dall CH, Thune JJ, Rasmusen H. Long-term left atrial adaptations to reduced training load in former elite athletes: a long-term follow-up longitudinal observational study. BMJ Open Sport Exerc Med. 2025 Apr 3;11(2):e002379. doi: 10.1136/bmjsem-2024-002379. eCollection 2025.
- Individual participant dataSharing planned: No. Registration After the provision of informed consent, each subject will be registered in a logged web-based register (REDCap). A list of registered participants will be kept linking the subject identification number. This list will be entered in a separate database and data will be encrypted. Information will not be passed on to a third party. Bispebjerg-Frederiksberg department of cardiology supervised by consultant doctor Hanne Kruuse Rasmusen will have the overall ownership and intellectual property rights to data collected in during this project.
Related trials for Athlete Heart
Recruiting
UCLA Magnesium Formulation Athlete Study
Athletic Performance, Recovery
Not yet recruiting
ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes
Coronary Atherosclerosis Due to Calcified Coronary Lesion
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases
RecruitingObservational study
Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
Sudden Cardiac Arrest, Sudden Cardiac Death
Recruiting
Effect of Hydrogen-rich Water During Tapering on Recovery After Functional Overreaching in Basketball Players
Healthy Active Athletes
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.
Hanne K Rasmusen, ph.d. principal investigator
Bispebjerg 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 Heart and Arrhythmias, Cardiac, run by Bispebjerg Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 5 Sep 2024. 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 Denmark. 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?
Left atrial minimum volume (time frame: 5 years). 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 NCT05555849, which also lists 1 linked publication.
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 Sep 2024.