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NCT05122962 Clinical Trial

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

Congenital Heart Disease Clinical Trial

— PACT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05122962
Other study ID # 21-005062
Secondary ID R01HL158517
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date October 2026

Study information
Verified date January 2024
Source Mayo Clinic
Contact Halley Davison
Phone 507-422-6246
Email RSTACHDRESPRG@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date October 2026
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Remote Heart Rhythm Monitoring
We will be looking to see if remote heart rhythm monitoring for 30 days at baseline, 12, and 24 months, helps for early identification of adverse cardiac events.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Right Heart Remodeling Right Heart Remodeling measured via right atrial reservoir strain (%). 24 Months
Secondary Incident arrhythmias Incident of atrial flutter, atrial fibrillation, atrial tachycardia, and/or ventricular tachycardia. 24 Months
Secondary Aerobic Capacity Aerobic Capacity measured as maximal oxygen consumption (ml/kg/min). 24 Months
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