Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining

Arrhythmias, Cardiac Clinical Trial

— Remod  

Official title:

Reverse Cardiac Remodeling Among Elite Athletes After Short and Long-term Detraining

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555849
• Other study ID #: Studie 3
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: April 30, 2029

Study information

• Verified date: March 2024
• Source: Bispebjerg Hospital
• Contact: Mikkel Aarøe, cand. med.
• Phone: 26802083
• Email: maar0041[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2029
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years at the time of screening

• Former elite athlete from endurance sport discipline

• End of elite sporting career >1 year ago

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Locations

Country	Name	City	State
Denmark	Bispebjerg-Frederiksberg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 years