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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03469843
Other study ID # PR(AMI)126/2015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 19, 2018
Est. completion date September 1, 2019

Study information

Verified date March 2022
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 25
Est. completion date September 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Non intervention
patients without intervention

Locations

Country Name City State
Spain Hospital Universitari Vall d'Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Grupper A, Gewirtz H, Kushwaha S. Reinnervation post-heart transplantation. Eur Heart J. 2018 May 21;39(20):1799-1806. doi: 10.1093/eurheartj/ehw604. Review. — View Citation

Khairy P, Clair M, Fernandes SM, Blume ED, Powell AJ, Newburger JW, Landzberg MJ, Mayer JE Jr. Cardiovascular outcomes after the arterial switch operation for D-transposition of the great arteries. Circulation. 2013 Jan 22;127(3):331-9. doi: 10.1161/CIRCU — View Citation

Kondo C, Nakazawa M, Momma K, Kusakabe K. Sympathetic denervation and reinnervation after arterial switch operation for complete transposition. Circulation. 1998 Jun 23;97(24):2414-9. — View Citation

Tobler D, Williams WG, Jegatheeswaran A, Van Arsdell GS, McCrindle BW, Greutmann M, Oechslin EN, Silversides CK. Cardiac outcomes in young adult survivors of the arterial switch operation for transposition of the great arteries. J Am Coll Cardiol. 2010 Ju — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial innervation pattern on 123I-mlBG SPECT. To describe the myocardial reinnervation pattern of a cohort of patients with TGA long after ASO using cardiac nuclear imaging. 1 day
Secondary Myocardial perfusion defects on cardiac nuclear imaging. To identify myocardial perfusion defects using cardiac nuclear imaging. 1 day
Secondary Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging. To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging. 1 day
Secondary Treadmill exercise test. 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.
1 day
Secondary 24 hours ECG Holter monitoring . 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)). 1 day
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