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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03469843
Enrollment
25
Registered
2018-03-19
Start date
2018-04-19
Completion date
2019-09-01
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defect, Congenital Heart Disease, Transposition of the Great Arteries

Keywords

Congenital Heart Disease, Cardiac denervation, 123I-metaiodobenzylguanidine, Arterial switch operation

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.

Interventions

OTHERNon intervention

patients without intervention

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with transposition of the great arteries repaired with the arterial switch. * Patients aged of more than 18 years-old.

Exclusion criteria

* Pregnancy or breast-feeding. * Denial of informed consent.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Myocardial perfusion defects on cardiac nuclear imaging.1 dayTo identify myocardial perfusion defects using cardiac nuclear imaging.
Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.1 dayTo identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
Treadmill exercise test.1 dayTo 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 dayTo 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)).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026