Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03469843

Collaborator

(none)

Enrollment

Location

16.4

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiac denervation is inherent to the arterial switch (ASO) technique for the repair of transposition of the great arteries (TGA) and the long term reinnervation process has not been studied. We sought to describe the reinnervation status of adult patients long after the ASO, to identify areas of myocardial perfusion/innervation mismatch and to assess the relation of innervation status and exercise capacity.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease Congenital Heart Defect Transposition of the Great Arteries	Other: Non intervention

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Characterization of the Cardiac Reinnervation of Patients With Transposition of the Great Arteries Long After Repair With the Arterial Switch Operation. Correlation With Electrocardiographic and Exercise Test Parameters

Actual Study Start Date :

Apr 19, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients patients with transposition of the great arteries long after repair with the arterial switch operation	Other: Non intervention patients without intervention Other Names: patients without intervention

Arm

Intervention/Treatment

Patients

patients with transposition of the great arteries long after repair with the arterial switch operation

Other: Non intervention

patients without intervention

Other Names:

patients without intervention

Outcome Measures

Primary Outcome Measures

Myocardial innervation pattern on 123I-mlBG SPECT. [1 day]
To describe the myocardial reinnervation pattern of a cohort of patients with TGA long after ASO using cardiac nuclear imaging.

Secondary Outcome Measures

Myocardial perfusion defects on cardiac nuclear imaging. [1 day]
To identify myocardial perfusion defects using cardiac nuclear imaging.
Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging. [1 day]
To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
Treadmill exercise test. [1 day]
To determine exercise capacity (METs and double product) and chronotropic response (Maximal heart rate and heart rate increase pattern). Correlate with myocardial reinnervation pattern and sinus node reinnervation. To determine exercise induced ischeamic ST segment changes. Correlate with myocardial perfusion defects and innervation-perfusion mismatch.
24 hours ECG Holter monitoring . [1 day]
To determine sinus node innervation through heart rate variability (HRV) which will be assessed by time domain variables (the standard deviation of normal RR intervals (SDNN) and the square root of the mean of the squared differences between adjacent normal RR intervals (r-MSSD)) and frequency domain variables (variance of all R-R intervals - total power (TP); power in the very low frequency range - very low frequency (VLF, 0.003-0.04 Hz); power in the low frequency range-low frequency (LF, 0.04-0.15Hz); low frequency power in normalized units-normalized low frequency; power in the high frequency range-high frequency (HF, 0.15-0.40 Hz); and high frequency power in normalized units-normalized high frequency and the ratio of low frequency to high frequency (LF/HF)).