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: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29
• 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.

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Exclusion Criteria

• Pregnant Women
• Unable to undergo CMRI

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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