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

NCT03469843 | Completed

• 1 other identifier: PR(AMI)126/2015
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Myocardial perfusion defects on cardiac nuclear imaging.

  1 day

• Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.

  1 day

• Treadmill exercise test.

  1 day

• 24 hours ECG Holter monitoring .

  1 day

Study Arms (1)

Patients

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

Other: Non intervention

Interventions

Non intervention OTHER

patients without intervention

Also known as: patients without intervention

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (4)

• 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.

  PMID: 20620718 RESULT

• 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.

  PMID: 23239839 RESULT

• 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.

  PMID: 9641693 RESULT

• 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.

  PMID: 28087606 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Transposition of Great Vessels

Interventions

Methods

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Laura Dos Subirà, PhD MD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: March 19, 2018
• Study Start: April 19, 2018
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)