Clinical trial NCT03469843: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Congenital Heart Defect
Transposition of the Great Arteries
Keywords: Congenital Heart Disease
Cardiac denervation
123I-metaiodobenzylguanidine
Arterial switch operation
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged of more than 18 years-old with transposition of the great arteries repaired with the arterial switch

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial innervation pattern on 123I-mlBG SPECT.
timeFrame: 1 day
Secondary outcomes:
measure: Myocardial perfusion defects on cardiac nuclear imaging.
timeFrame: 1 day
measure: Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.
timeFrame: 1 day
measure: Treadmill exercise test.
timeFrame: 1 day
measure: 24 hours ECG Holter monitoring .
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'hebron Barcelona, Spain
name: Laura Dos Subirà, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Jun 29;56(1):58-64. doi: 10.1016/j.jacc.2010.03.031.
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/CIRCULATIONAHA.112.135046. Epub 2012 Dec 12.
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. doi: 10.1161/01.cir.97.24.2414.
citation: 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.