ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03469843
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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.

Condition or disease Intervention/treatment
Congenital Heart Disease Congenital Heart Defect Transposition of the Great Arteries Other: Non intervention

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.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : September 1, 2019


Group/Cohort Intervention/treatment
Patients
patients with transposition of the great arteries long after repair with the arterial switch operation
Other: Non intervention
patients without intervention
Other Name: patients without intervention




Primary Outcome Measures :
  1. Myocardial innervation pattern on 123I-mlBG SPECT. [ Time Frame: 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 :
  1. Myocardial perfusion defects on cardiac nuclear imaging. [ Time Frame: 1 day ]
    To identify myocardial perfusion defects using cardiac nuclear imaging.

  2. Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging. [ Time Frame: 1 day ]
    To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.

  3. Treadmill exercise test. [ Time Frame: 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.


  4. 24 hours ECG Holter monitoring . [ Time Frame: 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)).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03469843


Contacts
Contact: Laura Dos Subirà, PhD MD 932746170 ldos@vhebron.net
Contact: Paula Resta Bond, MD presta@vhebron.net

Locations
Spain
Hospital Universitari Vall d`Hebron Recruiting
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: Laura Dos Subirà, PhD MD Hospital Universitari Vall d`Hebron , Barcelona, Spain

Publications of Results:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03469843     History of Changes
Other Study ID Numbers: PR(AMI)126/2015
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Congenital Heart Disease
Cardiac denervation
123I-metaiodobenzylguanidine
Arterial switch operation

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Situs Inversus
Transposition of Great Vessels
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities