Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

Recruiting

• Conditions: Tetralogy of Fallot; Congenital Heart Disease

• Registration Number: NCT05122962
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-04
• Study Start: 2021-11-01
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Right Heart Remodeling	24 Months	Right Heart Remodeling measured via right atrial reservoir strain (%).

Secondary Outcome Measures

Name	Time	Method
Incident arrhythmias	24 Months	Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia.
Aerobic Capacity	24 Months	Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States