Observational Study for Arrhythmias and Impaired Aerobic Capacity in Congenital Heart Disease
This observational study is looking at how symptoms like shortness of breath and heart palpitations, as well as changes in heart structure, develop in people with congenital heart disease (CHD). Researchers will use remote heart rhythm monitoring for 30 days at the start of the study, and again at 12 and 24 months, to see if it can help find heart problems early. The study is open to adults aged 18 and older with repaired Tetralogy of Fallot (TOF) or other congenital heart diseases like Ebstein's anomaly or Fontan palliation, especially if you have moderate or greater pulmonary regurgitation (PR) based on an echocardiogram. The main goal is to see how the right side of the heart changes over 24 months. The current status of this study is unclear, and it plans to enroll 300 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving any new treatments. It plans to include 300 participants.
- What's involved
- You would participate in remote heart rhythm monitoring for 30 days at the beginning of the study, and again at 12 and 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 24 months to observe changes in right heart remodeling.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
At a glance
Conditions
NCT05122962
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Rochester
Rochester, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alexander Egbe, MBBS, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Right Heart Remodeling24 Months
Right Heart Remodeling measured via right atrial reservoir strain (%).