Congenital Heart DiseaseNCT03469843
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
An observational study of Congenital Heart Disease and Congenital Heart Defect, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Heart Disease, Congenital Heart Defect, Transposition of the Great Arteries
- What is being tested?
- Non intervention
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 19 Apr 2018to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged of more than 18 years-old with transposition of the great arteries repaired with the arterial switch
Who may be able to join
- Patients with transposition of the great arteries repaired with the arterial switch.
- Patients aged of more than 18 years-old.
Who cannot join
- Pregnancy or breast-feeding.
- Denial of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Non intervention
- Keywords
- Congenital Heart Disease, Cardiac denervation, 123I-metaiodobenzylguanidine, Arterial switch operation
- Medical subject headings
- Heart Defects, Congenital, Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Also called patients without intervention
patients without intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients | patients with transposition of the great arteries long after repair with the arterial switch operation Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (4)
Myocardial perfusion defects on cardiac nuclear imaging.
To identify myocardial perfusion defects using cardiac nuclear imaging.
Measured: 1 day
Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.
To identify myocardial innervations/perfusion mismatch using cardiac nuclear imaging.
Measured: 1 day
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.
Measured: 1 day
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)).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start19 Apr 2018
- Primary completion1 Mar 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Dos Subirà, PhD MD, Principal investigator, Hospital Universitari Vall d'hebron Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469843
- Sponsor's protocol ID
- PR(AMI)126/2015
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2018
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20620718Khairy 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.
PubMed 23239839Kondo 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.
PubMed 9641693Grupper A, Gewirtz H, Kushwaha S. Reinnervation post-heart transplantation. Eur Heart J. 2018 May 21;39(20):1799-1806. doi: 10.1093/eurheartj/ehw604.
PubMed 28087606
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03469843
- Acronym / sponsor ID
- PR(AMI)126/2015
- Keywords
- Congenital Heart Disease, Cardiac denervation, 123I-metaiodobenzylguanidine, Arterial switch operation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Non interventionpatients with transposition of the great arteries long after repair with the arterial switch operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged of more than 18 years-old with transposition of the great arteries repaired with the arterial switch
Key inclusion criteria (2 listed)
- Patients with transposition of the great arteries repaired with the arterial switch.
- Patients aged of more than 18 years-old.
Key exclusion criteria (2 listed)
- Pregnancy or breast-feeding.
- Denial of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionAlso: patients without interventionpatients without intervention | Other | Patients |
Primary outcome
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.
4 secondary outcomes
Myocardial perfusion defects on cardiac nuclear imaging.
Time frame: 1 day
Myocardial innervation perfusion mismatch defects on cardiac nuclear imaging.
Time frame: 1 day
Treadmill exercise test.
Time frame: 1 day
24 hours ECG Holter monitoring .
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Results publication: PubMed 20620718Tobler 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.
- Results publication: PubMed 23239839Khairy 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.
- Results publication: PubMed 9641693Kondo 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.
- Results publication: PubMed 28087606Grupper A, Gewirtz H, Kushwaha S. Reinnervation post-heart transplantation. Eur Heart J. 2018 May 21;39(20):1799-1806. doi: 10.1093/eurheartj/ehw604.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dos Subirà, PhD MD principal investigator
Hospital Universitari Vall d'hebron Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Congenital Heart Defect, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial innervation pattern on 123I-mlBG SPECT. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469843, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.