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
- Conditions
- Congenital Heart DiseaseCongenital Heart DefectTransposition of the Great Arteries
- Interventions
- Other: Non intervention
- Registration Number
- NCT03469843
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Patients with transposition of the great arteries repaired with the arterial switch.
- Patients aged of more than 18 years-old.
- Pregnancy or breast-feeding.
- Denial of informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Non intervention patients with transposition of the great arteries long after repair with the arterial switch operation
- Primary Outcome Measures
Name Time Method 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
Name Time Method Myocardial perfusion defects on cardiac nuclear imaging. 1 day To identify myocardial perfusion defects 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.Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging. 1 day To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
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)).
Trial Locations
- Locations (1)
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain