Understanding heart issues in patients with congenital heart disease
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
This study is trying to understand what causes symptoms like shortness of breath and palpitations in people with congenital heart disease, especially those with Tetralogy of Fallot, by using remote heart monitoring.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05122962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the mechanisms that lead to symptoms such as shortness of breath and palpitations in patients with congenital heart disease, particularly those with Tetralogy of Fallot. It will utilize remote heart rhythm monitoring to gather data on heart structure and function. By analyzing these factors, the study seeks to improve understanding of how these conditions affect patients' health and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals with repaired Tetralogy of Fallot or other congenital heart diseases who exhibit moderate or greater pulmonary regurgitation.
Not a fit: Patients who are pregnant or unable to undergo cardiac MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management and treatment strategies for patients with congenital heart disease.
How similar studies have performed: Other studies have shown success in understanding arrhythmias and heart function in congenital heart disease, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Moderate (or greater) PR based on quantitative Doppler echocardiography. * Repaired TOF * Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries. Exclusion Criteria: * Pregnant Women * Unable to undergo CMRI
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Egbe, MBBS, MPH — Mayo Clinic
- Study coordinator: Halley Davison
- Email: RSTACHDRESPRG@mayo.edu
- Phone: 507-422-6246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.